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HIV Seropositivity: HELP
Articles by Craig R. Cohen
Based on 19 articles published since 2008
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Between 2008 and 2019, C. R. Cohen wrote the following 19 articles about HIV Seropositivity.
 
+ Citations + Abstracts
1 Clinical Trial Efficacy of oral pre-exposure prophylaxis (PrEP) for HIV among women with abnormal vaginal microbiota: a post-hoc analysis of the randomised, placebo-controlled Partners PrEP Study. 2017

Heffron, Renee / McClelland, R Scott / Balkus, Jennifer E / Celum, Connie / Cohen, Craig R / Mugo, Nelly / Bukusi, Elizabeth / Donnell, Deborah / Lingappa, Jairam / Kiarie, James / Fiedler, Tina / Munch, Matthew / Fredricks, David N / Baeten, Jared M / Anonymous5530913. ·Department of Global Health, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA. Electronic address: rheffron@uw.edu. · Department of Global Health, University of Washington, Seattle, WA, USA; Department of Epidemiology, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, WA, USA. · Department of Epidemiology, University of Washington, Seattle, WA, USA; Vaccine and Infectious Disease Division, Fred Hutch, Seattle, WA, USA. · Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA. · Department of Global Health, University of Washington, Seattle, WA, USA; Centre for Clinical Research, Nairobi, Kenya; Kenya Medical Research Institute, Nairobi, Kenya. · Department of Global Health, University of Washington, Seattle, WA, USA; Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA; Centre for Microbiology Research, Nairobi, Kenya. · Department of Global Health, University of Washington, Seattle, WA, USA; Vaccine and Infectious Disease Division, Fred Hutch, Seattle, WA, USA. · Department of Global Health, University of Washington, Seattle, WA, USA; Department of Medicine, University of Washington, Seattle, WA, USA; Department of Pediatrics, University of Washington, Seattle, WA, USA. · Human Reproduction Programme, WHO, Geneva, Switzerland. · Vaccine and Infectious Disease Division, Fred Hutch, Seattle, WA, USA. ·Lancet HIV · Pubmed #28732773.

ABSTRACT: BACKGROUND: Daily oral tenofovir-based pre-exposure prophylaxis (PrEP) is high efficacious for HIV prevention among women with high adherence. However, the effect of abnormal vaginal microbiota on PrEP efficacy is of concern. We investigated whether bacterial vaginosis modified the efficacy of oral PrEP. METHODS: We used prospectively collected data from women in the Partners PrEP Study, a placebo-controlled trial of daily oral PrEP (either tenofovir monotherapy or a combination of tenofovir and emtricitabine) in HIV serodiscordant couples aged 18 years or older in Kenya and Uganda that showed high efficacy in women. We used Cox proportional hazards regression to assess PrEP efficacy among subgroups of women defined by bacterial vaginosis status based on yearly microscopy and Nugent scoring (0-3 indicated healthy microbiota, 4-6 intermediate, and 7-10 bacterial vaginosis). In separate efficacy analyses, we also investigated individual components of the score (ie, detection of Gardnerella vaginalis or Bacteroides spp and non-detection of Lactobacillus spp) as markers of abnormal microbiota. FINDINGS: Of 1470 women (median age 33 years), 357 (24%) had bacterial vaginosis at enrolment. 45 women seroconverted to HIV. The HIV prevention efficacy of PrEP did not differ significantly among women with healthy microbiota (incidence 0·6 per 100 person years in PrEP group and 2·5 per 100 person-years in the placebo group; efficacy 76·55% [95% CI 43·09 to 90·37]), intermediate microbiota (HIV incidence 1·8 per 100 person-years in the PrEP group and 3·5 per 100 person-years in the placebo group; efficacy 62·72% [95% CI -66·59 to 91·66]), or bacterial vaginosis (HIV incidence 0·9 per 100 person-years in the PrEP group and 3·5 per 100 person-years in the placebo group; efficacy 72·50% [95% CI 5·98 to 91·95]; p INTERPRETATION: Among African women with a high prevalence of bacterial vaginosis and high adherence to PrEP, the efficacy of daily oral PrEP for HIV prevention did not differ significantly among women with abnormal versus healthy vaginal microbiota as defined by Nugent score. These data are reassuring that oral PrEP delivery to women can continue without the need for concurrent testing for bacterial vaginosis or vaginal dysbiosis. FUNDING: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and National Institute of Allergy and Infectious Diseases.

2 Clinical Trial Intimate Partner Violence and Adherence to HIV Pre-exposure Prophylaxis (PrEP) in African Women in HIV Serodiscordant Relationships: A Prospective Cohort Study. 2016

Roberts, Sarah T / Haberer, Jessica / Celum, Connie / Mugo, Nelly / Ware, Norma C / Cohen, Craig R / Tappero, Jordan W / Kiarie, James / Ronald, Allan / Mujugira, Andrew / Tumwesigye, Elioda / Were, Edwin / Irungu, Elizabeth / Baeten, Jared M / Anonymous18030869. ·*Department of Epidemiology, University of Washington, Seattle, WA; †Department of Medicine and Center for Global Health, Massachusetts General Hospital, Boston, MA; ‡Department of Global Health and Social Medicine, Harvard Medical School, Boston, MA; Departments of §Global Health; ‖Medicine, University of Washington, Seattle, WA; ¶Kenya Medical Research Institute, Nairobi, Kenya; #Division of Global Health Equity, Department of Medicine, Brigham and Women's Hospital, Boston, MA; **Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA; ††Centers for Disease Control and Prevention, Atlanta, GA; ‡‡Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya; §§Department of Medicine, University of Manitoba, Winnipeg, Canada; ‖‖Kabwohe Clinical Research Center, Kabwohe, Uganda; ¶¶Department of Reproductive Health, Moi University, Eldoret, Kenya; and ##Kenyatta National Hospital, Nairobi, Kenya. ·J Acquir Immune Defic Syndr · Pubmed #27243900.

ABSTRACT: BACKGROUND: Intimate partner violence (IPV) is associated with higher HIV incidence, reduced condom use, and poor adherence to antiretroviral therapy and other medications. IPV may also affect adherence to pre-exposure prophylaxis (PrEP). METHODS: We analyzed data from 1785 HIV-uninfected women enrolled in a clinical trial of PrEP among African HIV serodiscordant couples. Experience of verbal, physical, or economic IPV was assessed at monthly visits by face-to-face interviews. Low PrEP adherence was defined as clinic-based pill count coverage <80% or plasma tenofovir levels <40 ng/mL. The association between IPV and low adherence was analyzed using generalized estimating equations, adjusting for potential confounders. In-depth interview transcripts were examined to explain how IPV could impact adherence. RESULTS: Sixteen percent of women reported IPV during a median of 34.8 months of follow-up (interquartile range 27.0-35.0). Overall, 7% of visits had pill count coverage <80%, and 32% had plasma tenofovir <40 ng/mL. Women reporting IPV in the past 3 months had increased risk of low adherence by pill count (adjusted risk ratio 1.49, 95% confidence interval: 1.17 to 1.89) and by plasma tenofovir (adjusted risk ratio 1.51, 95% confidence interval: 1.06 to 2.15). Verbal, economic, and physical IPV were all associated with low adherence. However, the impact of IPV diminished and was not statistically significant 3 months after the reported exposure. In qualitative interviews, women identified several ways in which IPV affected adherence, including stress and forgetting, leaving home without pills, and partners throwing pills away. CONCLUSIONS: Women who reported recent IPV in the Partners PrEP Study were at increased risk of low PrEP adherence. Strategies to mitigate PrEP nonadherence in the context of IPV should be evaluated.

3 Clinical Trial Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. 2012

Baeten, Jared M / Donnell, Deborah / Ndase, Patrick / Mugo, Nelly R / Campbell, James D / Wangisi, Jonathan / Tappero, Jordan W / Bukusi, Elizabeth A / Cohen, Craig R / Katabira, Elly / Ronald, Allan / Tumwesigye, Elioda / Were, Edwin / Fife, Kenneth H / Kiarie, James / Farquhar, Carey / John-Stewart, Grace / Kakia, Aloysious / Odoyo, Josephine / Mucunguzi, Akasiima / Nakku-Joloba, Edith / Twesigye, Rogers / Ngure, Kenneth / Apaka, Cosmas / Tamooh, Harrison / Gabona, Fridah / Mujugira, Andrew / Panteleeff, Dana / Thomas, Katherine K / Kidoguchi, Lara / Krows, Meighan / Revall, Jennifer / Morrison, Susan / Haugen, Harald / Emmanuel-Ogier, Mira / Ondrejcek, Lisa / Coombs, Robert W / Frenkel, Lisa / Hendrix, Craig / Bumpus, Namandjé N / Bangsberg, David / Haberer, Jessica E / Stevens, Wendy S / Lingappa, Jairam R / Celum, Connie / Anonymous2030731. ·Department of Global Health, University of Washington, Seattle, WA 98104, USA. jbaeten@uw.edu ·N Engl J Med · Pubmed #22784037.

ABSTRACT: BACKGROUND: Antiretroviral preexposure prophylaxis is a promising approach for preventing human immunodeficiency virus type 1 (HIV-1) infection in heterosexual populations. METHODS: We conducted a randomized trial of oral antiretroviral therapy for use as preexposure prophylaxis among HIV-1-serodiscordant heterosexual couples from Kenya and Uganda. The HIV-1-seronegative partner in each couple was randomly assigned to one of three study regimens--once-daily tenofovir (TDF), combination tenofovir-emtricitabine (TDF-FTC), or matching placebo--and followed monthly for up to 36 months. At enrollment, the HIV-1-seropositive partners were not eligible for antiretroviral therapy, according to national guidelines. All couples received standard HIV-1 treatment and prevention services. RESULTS: We enrolled 4758 couples, of whom 4747 were followed: 1584 randomly assigned to TDF, 1579 to TDF-FTC, and 1584 to placebo. For 62% of the couples followed, the HIV-1-seronegative partner was male. Among HIV-1-seropositive participants, the median CD4 count was 495 cells per cubic millimeter (interquartile range, 375 to 662). A total of 82 HIV-1 infections occurred in seronegative participants during the study, 17 in the TDF group (incidence, 0.65 per 100 person-years), 13 in the TDF-FTC group (incidence, 0.50 per 100 person-years), and 52 in the placebo group (incidence, 1.99 per 100 person-years), indicating a relative reduction of 67% in the incidence of HIV-1 with TDF (95% confidence interval [CI], 44 to 81; P<0.001) and of 75% with TDF-FTC (95% CI, 55 to 87; P<0.001). Protective effects of TDF-FTC and TDF alone against HIV-1 were not significantly different (P=0.23), and both study medications significantly reduced the HIV-1 incidence among both men and women. The rate of serious adverse events was similar across the study groups. Eight participants receiving active treatment were found to have been infected with HIV-1 at baseline, and among these eight, antiretroviral resistance developed in two during the study. CONCLUSIONS: Oral TDF and TDF-FTC both protect against HIV-1 infection in heterosexual men and women. (Funded by the Bill and Melinda Gates Foundation; Partners PrEP ClinicalTrials.gov number, NCT00557245.).

4 Article High rates of viral suppression in adults and children with high CD4+ counts using a streamlined ART delivery model in the SEARCH trial in rural Uganda and Kenya. 2017

Kwarisiima, Dalsone / Kamya, Moses R / Owaraganise, Asiphas / Mwangwa, Florence / Byonanebye, Dathan M / Ayieko, James / Plenty, Albert / Black, Doug / Clark, Tamara D / Nzarubara, Bridget / Snyman, Katherine / Brown, Lillian / Bukusi, Elizabeth / Cohen, Craig R / Geng, Elvin H / Charlebois, Edwin D / Ruel, Theodore D / Petersen, Maya L / Havlir, Diane / Jain, Vivek. ·Infectious Diseases Research Collaboration, Kampala, Uganda. · School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda. · Kenya Medical Research Institute, Nairobi, Kenya. · Division of HIV, Infectious Diseases & Global Medicine, University of California, San Francisco, CA, USA. · Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, CA, USA. · Division of Infectious Diseases, Department of Pediatrics, University of California, San Francisco, CA, USA. · Department of Biostatistics and Epidemiology, Berkeley School of Public Health, Berkeley, CA, USA. ·J Int AIDS Soc · Pubmed #28770596.

ABSTRACT: INTRODUCTION: The 2015 WHO recommendation of antiretroviral therapy (ART) for all HIV-positive persons calls for treatment initiation in millions of persons newly eligible with high CD4+ counts. Efficient and effective care models are urgently needed for this population. We evaluated clinical outcomes of asymptomatic HIV-positive adults and children starting ART with high CD4+ counts using a novel streamlined care model in rural Uganda and Kenya. METHODS: In the 16 intervention communities of the HIV test-and-treat Sustainable East Africa Research for Community Health Study (NCT01864603), all HIV-positive individuals irrespective of CD4 were offered ART (efavirenz [EFV]/tenofovir disoproxil fumarate + emtricitabine (FTC) or lamivudine (3TC). We studied adults (≥fifteen years) with CD4 ≥ 350/μL and children (two to fourteen years) with CD4 > 500/μL otherwise ineligible for ART by country guidelines. Clinics implemented a patient-centred streamlined care model designed to reduce patient-level barriers and maximize health system efficiency. It included (1) nurse-conducted visits with physician referral of complex cases, (2) multi-disease chronic care (including for hypertension/diabetes), (3) patient-centred, friendly staff, (4) viral load (VL) testing and counselling, (5) three-month return visits and ART refills, (6) appointment reminders, (7) tiered tracking for missed appointments, (8) flexible clinic hours (outside routine schedule) and (9) telephone access to clinicians. Primary outcomes were 48-week retention in care, viral suppression (% with measured week 48 VL ≤ 500 copies/mL) and adverse events. CONCLUSIONS: Using a streamlined care model, viral suppression, retention and ART safety were high among asymptomatic East African adults and children with high CD4+ counts initiating treatment. CLINICAL TRIAL NUMBER: NCT01864603.

5 Article Association of Implementation of a Universal Testing and Treatment Intervention With HIV Diagnosis, Receipt of Antiretroviral Therapy, and Viral Suppression in East Africa. 2017

Petersen, Maya / Balzer, Laura / Kwarsiima, Dalsone / Sang, Norton / Chamie, Gabriel / Ayieko, James / Kabami, Jane / Owaraganise, Asiphas / Liegler, Teri / Mwangwa, Florence / Kadede, Kevin / Jain, Vivek / Plenty, Albert / Brown, Lillian / Lavoy, Geoff / Schwab, Joshua / Black, Douglas / van der Laan, Mark / Bukusi, Elizabeth A / Cohen, Craig R / Clark, Tamara D / Charlebois, Edwin / Kamya, Moses / Havlir, Diane. ·School of Public Health, University of California, Berkeley. · University of California, San Francisco3Harvard T. H. Chan School of Public Health, Boston, Massachusetts. · Infectious Diseases Research Collaboration, Kampala, Uganda. · Kenya Medical Research Institute, Nairobi, Kenya. · University of California, San Francisco. · Infectious Diseases Research Collaboration, Kampala, Uganda6Makerere University, Kampala, Uganda. ·JAMA · Pubmed #28586888.

ABSTRACT: Importance: Antiretroviral treatment (ART) is now recommended for all HIV-positive persons. UNAIDS has set global targets to diagnose 90% of HIV-positive individuals, treat 90% of diagnosed individuals with ART, and suppress viral replication among 90% of treated individuals, for a population-level target of 73% of all HIV-positive persons with HIV viral suppression. Objective: To describe changes in the proportions of HIV-positive individuals with HIV viral suppression, HIV-positive individuals who had received a diagnosis, diagnosed individuals treated with ART, and treated individuals with HIV viral suppression, following implementation of a community-based testing and treatment program in rural East Africa. Design, Setting, and Participants: Observational analysis based on interim data from 16 rural Kenyan (n = 6) and Ugandan (n = 10) intervention communities in the SEARCH Study, an ongoing cluster randomized trial. Community residents who were 15 years or older (N = 77 774) were followed up for 2 years (2013-2014 to 2015-2016). HIV serostatus and plasma HIV RNA level were measured annually at multidisease health campaigns followed by home-based testing for nonattendees. All HIV-positive individuals were offered ART using a streamlined delivery model designed to reduce structural barriers, improve patient-clinician relationships, and enhance patient knowledge and attitudes about HIV. Main Outcomes and Measures: Primary outcome was viral suppression (plasma HIV RNA<500 copies/mL) among all HIV-positive individuals, assessed at baseline and after 1 and 2 years. Secondary outcomes included HIV diagnosis, ART among previously diagnosed individuals, and viral suppression among those who had initiated ART. Results: Among 77 774 residents (male, 45.3%; age 15-24 years, 35.1%), baseline HIV prevalence was 10.3% (7108 of 69 283 residents). The proportion of HIV-positive individuals with HIV viral suppression at baseline was 44.7% (95% CI, 43.5%-45.9%; 3464 of 7745 residents) and after 2 years of intervention was 80.2% (95% CI, 79.1%-81.2%; 5666 of 7068 residents), an increase of 35.5 percentage points (95% CI, 34.4-36.6). After 2 years, 95.9% of HIV-positive individuals had been previously diagnosed (95% CI, 95.3%-96.5%; 6780 of 7068 residents); 93.4% of those previously diagnosed had received ART (95% CI, 92.8%-94.0%; 6334 of 6780 residents); and 89.5% of those treated had achieved HIV viral suppression (95% CI, 88.6%-90.3%; 5666 of 6334 residents). Conclusions and Relevance: Among individuals with HIV in rural Kenya and Uganda, implementation of community-based testing and treatment was associated with an increased proportion of HIV-positive adults who achieved viral suppression, along with increased HIV diagnosis and initiation of antiretroviral therapy. In these communities, the UNAIDS population-level viral suppression target was exceeded within 2 years after program implementation. Trial Registration: clinicaltrials.gov Identifier: NCT01864683.

6 Article Expectations about future health and longevity in Kenyan and Ugandan communities receiving a universal test-and-treat intervention in the SEARCH trial. 2016

Thirumurthy, Harsha / Jakubowski, Aleksandra / Camlin, Carol / Kabami, Jane / Ssemmondo, Emmanuel / Elly, Assurah / Mwai, Daniel / Clark, Tamara / Cohen, Craig / Bukusi, Elizabeth / Kamya, Moses / Petersen, Maya / Havlir, Diane / Charlebois, Edwin D. ·a Department of Health Policy and Management , Gillings School of Global Public Health, University of North Carolina at Chapel Hill , Chapel Hill , NC , USA. · b Department of Obstetrics, Gynecology and Reproductive Sciences , University of California San Francisco , San Francisco , CA , USA. · c Makerere University-University of California Research Collaboration , Kampala , Uganda. · d Kenya Medical Research Institute , Nairobi , Kenya. · e The Palladium Group , Nairobi , Kenya. · f Division of HIV, Infectious Diseases and Global Medicine, University of California San Francisco , San Francisco, CA , USA. · g Department of Medicine, School of Medicine, Makerere University College of Health Sciences , Kampala , Uganda. · h University of California Berkeley School of Public Health , Berkeley, CA , USA. · i Department of Medicine and Center for AIDS Prevention Studies, University of California San Francisco , San Francisco, CA , USA. ·AIDS Care · Pubmed #27421056.

ABSTRACT: Expectations about future health and longevity are important determinants of individuals' decisions to invest in physical and human capital. Few population-level studies have measured subjective expectations and examined how they are affected by scale-up of antiretroviral therapy (ART). We assessed these expectations in communities receiving annual HIV testing and universal ART. Longitudinal data on expectations were collected at baseline and one year later in 16 intervention communities participating in the Sustainable East Africa Research in Community Health (SEARCH) trial of the test and treat strategy in Kenya and Uganda (NCT01864603). A random sample of households with and without an HIV-positive adult was selected after baseline HIV testing. Individuals' expectations about survival to 50, 60, 70, and 80 years of age, as well as future health status and economic well-being, were measured using a Likert scale. Primary outcomes were binary variables indicating participants who reported being very likely or almost certain to survive to advanced ages. Logistic regression analyses were used to examine trends in expectations as well as associations with HIV status and viral load for HIV-positive individuals. Data were obtained from 3126 adults at baseline and 3977 adults in year 1, with 2926 adults participating in both waves. HIV-negative adults were more likely to have favorable expectations about survival to 60 years than HIV-positive adults with detectable viral load (adjusted odds ratio [AOR] 1.87, 95% CI 1.53-2.30), as were HIV-positive adults with undetectable viral load (AOR 1.41, 95% CI 1.13-1.77). Favorable expectations about survival to 60 years were more likely for all groups in year 1 compared to baseline (AOR 1.53, 95% CI 1.31-1.77). These findings are consistent with the hypothesis that universal ART leads to improved population-level expectations about future health and well-being. Future research from the SEARCH trial will help determine whether these changes are causally driven by the provision of universal ART.

7 Article Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial. 2016

Onu, Chinwe / Ongeri, Linnet / Bukusi, Elizabeth / Cohen, Craig R / Neylan, Thomas C / Oyaro, Patrick / Rota, Grace / Otewa, Faith / Delucchi, Kevin L / Meffert, Susan M. ·School of Medicine, University of California, San Francisco, 500 Parnassus Avenue, San Francisco, CA, 94121, USA. chinwe.onu@ucsf.edu. · Kenya Medical Research Institute, PO Box 54840, 00200, Nairobi, Kenya. longeri@kemri.org. · Department of Psychiatry, University of Nairobi, Kenya, PO Box 19676, Nairobi, Kenya. ebukusi@kemri.org. · Department of Obstetrics and Gynecology, University of Nairobi, Kenya, PO Box 19676, Nairobi, Kenya. ebukusi@kemri.org. · Department of Obstetrics and Gynecology, University of California, San Francisco, 550 16th Street, San Francisco, CA, 94158, USA. ccohen@globalhealth.ucsf.edu. · Department of Psychiatry, University of California, San Francisco, 4150 Clement Street, San Francisco, CA, 94121, USA. Thomas.Neylan@ucsf.edu. · Family AIDS Care Education and Services, Kenya, PO Box 614-40100, Kisumu, Kenya. Poyaro@kemri-ucsf.org. · Family AIDS Care Education and Services, Kenya, PO Box 614-40100, Kisumu, Kenya. grcrota@gmail.com. · Family AIDS Care Education and Services, Kenya, PO Box 614-40100, Kisumu, Kenya. fotewa@kemri-ucsf.org. · Department of Psychiatry, University of California, San Francisco, 401 Parnassus avenue, San Francisco, CA, 94143, USA. Kevin.delucchi@ucsf.edu. · Department of Psychiatry, University of California, San Francisco, 401 Parnassus avenue, San Francisco, CA, 94143, USA. Susan.meffert@ucsf.edu. ·Trials · Pubmed #26841875.

ABSTRACT: BACKGROUND: Mental disorders are the leading global cause of years lived with disability; the majority of this burden exists in low and middle income countries (LMICs). Over half of mental illness is attributable to depression and anxiety disorders, both of which have known treatments. While the scarcity of mental health care providers is recognized as a major contributor to the magnitude of untreated disorders in LMICs, studies in LMICs find that evidence-based treatments for depression and anxiety disorders, such as brief, structured psychotherapies, are feasible, acceptable and have strong efficacy when delivered by local non-specialist personnel. However, most mental health treatment studies using non-specialist providers in LMICs deploy traditional efficacy designs (T1) without the benefit of integrated mental health treatment models shown to succeed over vertical interventions or methods derived from new implementation science to speed policy change. Here, we describe an effectiveness-implementation hybrid study that evaluates non-specialist delivery of mental health treatment within an HIV clinic for HIV-positive (HIV+) women affected by gender- based violence (GBV) (HIV+ GBV+) in the Nyanza region of Kenya. METHODS/DESIGN: In this effectiveness-implementation hybrid type I design, 200 HIV+ women with major depressive disorder (MDD) and posttraumatic stress disorder (PTSD) who are receiving care at a Family AIDS Care Education and Services (FACES)-supported clinic in Kisumu, Kenya will be randomized to: (1) interpersonal psychotherapy (IPT) + treatment as usual (TAU) or (2) TAU, both delivered within the HIV clinic. IPT will consist of 12 weekly 60-minute individual IPT sessions, delivered by non-specialists trained to provide IPT. Primary effectiveness outcomes will include MDD and PTSD diagnosis on the Mini International Diagnostic Interview (MINI). Primary implementation outcomes will include treatment cost-benefit, acceptability, appropriateness, feasibility and fidelity of the IPT delivery within an HIV clinic. DISCUSSION: This trial leverages newly defined effectiveness-implementation hybrid designs to gather data on mental health treatment implementation within an HIV care clinic, while testing the effectiveness of an evidence-based treatment for use with a large underserved population (HIV+ GBV+ women) in Kenya. CLINICAL TRIALS IDENTIFIER: NCT02320799, registered on 9 September 2014.

8 Article A Scoring Tool to Identify East African HIV-1 Serodiscordant Partnerships with a High Likelihood of Pregnancy. 2015

Heffron, Renee / Cohen, Craig R / Ngure, Kenneth / Bukusi, Elizabeth / Were, Edwin / Kiarie, James / Mugo, Nelly / Celum, Connie / Baeten, Jared M / Anonymous5941063. ·Department of Global Health, University of Washington, Seattle, United States of America. · Department of Epidemiology, University of Washington, Seattle, United States of America. · Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, United States of America. · Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya. · Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya. · Department of Reproductive Health, Moi University, Eldoret, Kenya. · Department of Obstetrics and Gynaecology, University of Nairobi, Nairobi, Kenya. · Center for Clinical Research, Kenya Medical Research Institute, Nairobi, Kenya. · Department of Obstetrics & Gynecology, Kenya Medical Research Institute, Nairobi, Kenya. · Department of Medicine, University of Washington, Seattle, United States of America. ·PLoS One · Pubmed #26720412.

ABSTRACT: INTRODUCTION: HIV-1 prevention programs targeting HIV-1 serodiscordant couples need to identify couples that are likely to become pregnant to facilitate discussions about methods to minimize HIV-1 risk during pregnancy attempts (i.e. safer conception) or effective contraception when pregnancy is unintended. A clinical prediction tool could be used to identify HIV-1 serodiscordant couples with a high likelihood of pregnancy within one year. METHODS: Using standardized clinical prediction methods, we developed and validated a tool to identify heterosexual East African HIV-1 serodiscordant couples with an increased likelihood of becoming pregnant in the next year. Datasets were from three prospectively followed cohorts, including nearly 7,000 couples from Kenya and Uganda participating in HIV-1 prevention trials and delivery projects. RESULTS: The final score encompassed the age of the woman, woman's number of children living, partnership duration, having had condomless sex in the past month, and non-use of an effective contraceptive. The area under the curve (AUC) for the probability of the score to correctly predict pregnancy was 0.74 (95% CI 0.72-0.76). Scores ≥ 7 predicted a pregnancy incidence of >17% per year and captured 78% of the pregnancies. Internal and external validation confirmed the predictive ability of the score. DISCUSSION: A pregnancy likelihood score encompassing basic demographic, clinical and behavioral factors defined African HIV-1 serodiscordant couples with high one-year pregnancy incidence rates. This tool could be used to engage African HIV-1 serodiscordant couples in counseling discussions about fertility intentions in order to offer services for safer conception or contraception that align with their reproductive goals.

9 Article Linkage to HIV care, postpartum depression, and HIV-related stigma in newly diagnosed pregnant women living with HIV in Kenya: a longitudinal observational study. 2014

Turan, Bulent / Stringer, Kristi L / Onono, Maricianah / Bukusi, Elizabeth A / Weiser, Sheri D / Cohen, Craig R / Turan, Janet M. ·Department of Psychology, University of Alabama at Birmingham, CH 415, 1530 3rd Avenue South, Birmingham, AL, 35294-1170, USA. bturanb@gmail.com. · Department of Sociology, University of Alabama at Birmingham, HHB 460, 1720 2nd Ave South, Birmingham, AL, 35294-1152, USA. Kls5n@uab.edu. · Centre for Microbiology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya. maricianah@yahoo.com. · Centre for Microbiology Research, Kenya Medical Research Institute (KEMRI), Nairobi, Kenya. ebukusi@rctp.or.ke. · Department of Medicine, University of California, San Francisco, San Francisco, CA, USA. Sheri.Weiser@ucsf.edu. · Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA. CCohen@globalhealth.ucsf.edu. · Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA. jmturan@uab.edu. ·BMC Pregnancy Childbirth · Pubmed #25467187.

ABSTRACT: BACKGROUND: While studies have suggested that depression and HIV-related stigma may impede access to care, a growing body of literature also suggests that access to HIV care itself may help to decrease internalized HIV-related stigma and symptoms of depression in the general population of persons living with HIV. However, this has not been investigated in postpartum women living with HIV. Furthermore, linkage to care itself may have additional impacts on postpartum depression beyond the effects of antiretroviral therapy. We examined associations between linkage to HIV care, postpartum depression, and internalized stigma in a population with a high risk of depression: newly diagnosed HIV-positive pregnant women. METHODS: In this prospective observational study, data were obtained from 135 HIV-positive women from eight antenatal clinics in the rural Nyanza Province of Kenya at their first antenatal visit (prior to testing HIV-positive for the first time) and subsequently at 6 weeks after giving birth. RESULTS: At 6 weeks postpartum, women who had not linked to HIV care after testing positive at their first antenatal visit had higher levels of depression and internalized stigma, compared to women who had linked to care. Internalized stigma mediated the effect of linkage to care on depression. Furthermore, participants who had both linked to HIV care and initiated antiretroviral therapy reported the lowest levels of depressive symptoms. CONCLUSIONS: These results provide further support for current efforts to ensure that women who are newly diagnosed with HIV during pregnancy become linked to HIV care as early as possible, with important benefits for both physical and mental health.

10 Article HIV serostatus and disclosure: implications for infant feeding practice in rural south Nyanza, Kenya. 2014

Onono, Maricianah A / Cohen, Craig R / Jerop, Mable / Bukusi, Elizabeth A / Turan, Janet M. ·Kenya Medical Research Institute (KEMRI), Kisumu, Kenya. maricianah@yahoo.com. ·BMC Public Health · Pubmed #24754975.

ABSTRACT: BACKGROUND: The World Health Organization (WHO) recommends that HIV-infected women practice exclusive breastfeeding (EBF) for the first 6 months postpartum to reduce HIV transmission. The aim of this study was to determine the effects of HIV/AIDS knowledge and other psychosocial factors on EBF practice among pregnant and postpartum women in rural Nyanza, Kenya, an area with a high prevalence of HIV. METHODS: Data on baseline characteristics and knowledge during pregnancy, as well as infant feeding practices 4-8 weeks after the birth were obtained from 281 pregnant women recruited from nine antenatal clinics. Factors examined included: fear of HIV/AIDS stigma, male partner reactions, lack of disclosure to family members, knowledge of prevention of mother-to-child transmission (PMTCT) and mental health. In the analysis, comparisons were made using chi-squared and t-test methods as well as logistic multivariate regression models. RESULTS: There were high levels of anticipated stigma 171(61.2%), intimate partner violence 57(20.4%) and postpartum depression 29(10.1%) and low levels of disclosure among HIV positive women 30(31.3%). The most significant factors determining EBF practice were hospital delivery (aOR = 2.1 95% CI 1.14-3.95) HIV positive serostatus (aOR 2.5 95% CI 1.23-5.27), and disclosure of HIV-positive serostatus (aOR 2.9 95% CI 1.31-6.79). Postpartum depression and PMTCT knowledge were not associated with EBF (aOR 1.1 95% CI 0.47-2.62 and aOR 1.2 95% CI 0.64-2.24) respectively. CONCLUSIONS: Health care workers and counselors need to receive support in order to improve skills required for diagnosing, monitoring and managing psychosocial aspects of the care of pregnant and HIV positive women including facilitating disclosure to male partners in order to improve both maternal and child health outcomes.

11 Article Fertility intentions among HIV-infected, sero-concordant couples in Nyanza province, Kenya. 2013

Withers, Mellissa / Dworkin, Shari / Harrington, Elizabeth / Kwena, Zachary / Onono, Maricianah / Bukusi, Elizabeth / Cohen, Craig R / Grossman, Daniel / Newmann, Sara J. ·a Department of Anthropology , University of California , Los Angeles , USA. ·Cult Health Sex · Pubmed #23885924.

ABSTRACT: Research in sub-Saharan Africa has shown significant diversity in how HIV influences infected couples' fertility intentions. Supporting HIV-infected, sero-concordant couples in sub-Saharan Africa to make informed choices about their fertility options has not received sufficient attention. In-depth interviews were conducted among 23 HIV-positive, sero-concordant married couples in Kenya, to better understand how HIV impacted fertility intentions. HIV compelled many to reconsider fertility plans, sometimes promoting childbearing intentions in some individuals but reducing fertility plans among most, largely due to fears of early death, health concerns, stigma, perinatal HIV transmission and financial difficulties (particularly in men). Preferences for sons and large families influenced some couples' intentions to continue childbearing, although none had discussed their intentions with healthcare providers. Additional support and services for HIV-infected, sero-concordant couples are needed. Family planning counselling should be tailored to the unique concerns of HIV-infected couples, addressing perinatal transmission but also individual, couple-level and socio-cultural fertility expectations. Community-level programmes are needed to reduce stigma and make HIV-infected couples more comfortable in discussing fertility intentions with healthcare providers.

12 Article Multiple human papillomavirus infections and HIV seropositivity as risk factors for abnormal cervical cytology among female sex workers in Nairobi. 2013

Patel, S J / Mugo, N R / Cohen, C R / Ting, J / Nguti, R / Kwatampora, J / Waweru, W / Patnaik, P / Donders, G G / Kimani, J / Kenney, D L / Kiviat, N B / Smith, J S. ·Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA. ·Int J STD AIDS · Pubmed #23535357.

ABSTRACT: We estimated type-specific prevalence of human papillomavirus (HPV) and examined risk factors for abnormal cervical cytology among 296 female sex workers from Nairobi, Kenya. Over half (54%) were infected with a high-risk (HR) HPV type, of which HPV16 and 52 were the most common types. HIV-1 prevalence was 23% and HIV-1 sero-positivity was associated with high-grade cervical lesions, particularly among women with CD4 count less than 500 cells/mm(3) (odds ratio [OR] = 6.9; 95% confidence interval [CI]: 1.7-24.9). Among women who had normal cytology at the time of entry into the study, the risk of having an abnormal Pap smear within one year was significantly elevated for women with multiple HPV types at study entry (adjusted odds ratio [aOR] = 6.0; 95% CI: 2.3-15.7) and with a subset of HR HPV types (aOR = 4.2; 95% CI: 1.6-11.2). Detection of multiple concurrent HPV infections may be a useful marker to identify women at risk of developing precancerous lesions in populations of high HPV prevalence.

13 Article Bacterial vaginosis associated with increased risk of female-to-male HIV-1 transmission: a prospective cohort analysis among African couples. 2012

Cohen, Craig R / Lingappa, Jairam R / Baeten, Jared M / Ngayo, Musa O / Spiegel, Carol A / Hong, Ting / Donnell, Deborah / Celum, Connie / Kapiga, Saidi / Delany, Sinead / Bukusi, Elizabeth A. ·Department of Obstetrics, Gynecology and Reproductive Sciences, University of California San Francisco, San Francisco, United States of America. ccohen@globalhealth.ucsf.edu ·PLoS Med · Pubmed #22745608.

ABSTRACT: BACKGROUND: Bacterial vaginosis (BV), a disruption of the normal vaginal flora, has been associated with a 60% increased risk of HIV-1 acquisition in women and higher concentration of HIV-1 RNA in the genital tract of HIV-1-infected women. However, whether BV, which is present in up to half of African HIV-1-infected women, is associated with an increase in HIV-1 transmission to male partners has not been assessed in previous studies. METHODS AND FINDINGS: We assessed the association between BV on female-to-male HIV-1 transmission risk in a prospective study of 2,236 HIV-1-seropositive women and their HIV-1 uninfected male partners from seven African countries from a randomized placebo-controlled trial that enrolled heterosexual African adults who were seropositive for both HIV-1 and herpes simplex virus (HSV)-2, and their HIV-1-seronegative partners. Participants were followed for up to 24 months; every three months, vaginal swabs were obtained from female partners for Gram stain and male partners were tested for HIV-1. BV and normal vaginal flora were defined as a Nugent score of 7-10 and 0-3, respectively. To reduce misclassification, HIV-1 sequence analysis of viruses from seroconverters and their partners was performed to determine linkage of HIV-1 transmissions. Overall, 50 incident HIV-1 infections occurred in men in which the HIV-1-infected female partner had an evaluable vaginal Gram stain. HIV-1 incidence in men whose HIV-1-infected female partners had BV was 2.91 versus 0.76 per 100 person-years in men whose female partners had normal vaginal flora (hazard ratio 3.62, 95% CI 1.74-7.52). After controlling for sociodemographic factors, sexual behavior, male circumcision, sexually transmitted infections, pregnancy, and plasma HIV-1 RNA levels in female partners, BV was associated with a greater than 3-fold increased risk of female-to-male HIV-1 transmission (adjusted hazard ratio 3.17, 95% CI 1.37-7.33). CONCLUSIONS: This study identified an association between BV and increased risk of HIV-1 transmission to male partners. Several limitations may affect the generalizability of our results including: all participants underwent couples HIV counseling and testing and enrolled in an HIV-1 prevention trial, and index participants had a baseline CD4 count ≥ 250 cells/mm³ and were HSV-2 seropositive. Given the high prevalence of BV and the association of BV with increased risk of both female HIV-1 acquisition and transmission found in our study, if this association proves to be causal, BV could be responsible for a substantial proportion of new HIV-1 infections in Africa. Normalization of vaginal flora in HIV-1-infected women could mitigate female-to-male HIV-1 transmission. TRIAL REGISTRATION: ClinicalTrials.com NCT00194519.

14 Article Contraceptive method and pregnancy incidence among women in HIV-1-serodiscordant partnerships. 2012

Ngure, Kenneth / Heffron, Renee / Mugo, Nelly R / Celum, Connie / Cohen, Craig R / Odoyo, Josephine / Rees, Helen / Kiarie, James N / Were, Edwin / Baeten, Jared M / Anonymous4850712. ·Department of Obstetrics and Gynaecology, Kenyatta National Hospital, Nairobi, Kenya. ·AIDS · Pubmed #22156966.

ABSTRACT: BACKGROUND: Effective contraception reduces unintended pregnancies and is a central strategy to reduce vertical HIV-1 transmission for HIV-1-infected women. METHODS: Among 2269 HIV-1-seropositive and 1085-seronegative women from seven African countries who were members of HIV-1-serodiscordant heterosexual partnerships and who were participating in an HIV-1 prevention clinical trial, we assessed pregnancy incidence according to contraceptive method using multivariate Andersen-Gill analysis. RESULTS: Compared with women using no contraceptive method, pregnancy incidence was significantly reduced among HIV-1-seropositive and HIV-1-seronegative women using injectable contraception [adjusted hazard ratio (aHR) 0.24, P = 0.001 and aHR 0.25, P < 0.001, respectively). Oral contraceptives significantly reduced pregnancy risk only among HIV-1-seropositive women (aHR 0.51, P = 0.004) but not seronegative women (aHR 0.64, P = 0.3), and, for both seropositive and seronegative women, oral contraceptive pill users were more likely to become pregnant than injectable contraceptive users (aHR 2.22, P = 0.01 for HIV-1-seropositive women and aHR 2.65, P = 0.09 for HIV-1-seronegative women). Condoms, when reported as being used as the primary contraceptive method, marginally reduced pregnancy incidence (aHR 0.85, P = 0.1 for seropositive women and aHR 0.67, P = 0.02 for seronegative women). There were no pregnancies among women using intrauterine devices, implantable methods or who had undergone surgical sterilization, although these methods were used relatively infrequently. CONCLUSION: Family planning programs and HIV-1 prevention trials need innovative ways to motivate uptake and sustained use of longer acting, less user-dependent contraception for women who do not desire pregnancy.

15 Article Attitudes and beliefs about anti-retroviral therapy are associated with high risk sexual behaviors among the general population of Kisumu, Kenya. 2011

Smith, Rachel M / Carrico, Adam W / Montandon, Michele / Kwena, Zachary / Bailey, Robert / Bukusi, Elizabeth A / Cohen, Craig R. ·Departments of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, USA. rachel.smith@ucsf.edu ·AIDS Care · Pubmed #22050441.

ABSTRACT: Attitudes and beliefs about antiretroviral therapy (ART) may affect sexual risk behaviors among the general population in sub-Saharan Africa. We performed a cross-sectional population-based study in Kisumu, Kenya to test this hypothesis in October 2006. A total of 1655 participants were interviewed regarding attitudes and beliefs about ART and their sexual risk behaviors. The majority of participants, (71%) men and (70%) women, had heard of ART. Of these, 20% of men and 29% of women believed ART cures HIV. Among women, an attitude that "HIV is more controllable now that ART is available" was associated with sex with a non-spousal partner, increased lifetime number of sexual partners as well as a younger age at sexual debut. No significant associations with this factor were found among men. The belief that "ART cures HIV" was associated with younger age of sexual debut among women. The same belief was associated with an increased likelihood of exchanging sex for money/gifts and decreased likelihood of condom use at last sex among men. These findings were most significant for people aged 15-29 years. In high HIV seroprevalence populations with expanding access to ART, prevention programs must ensure their content counteracts misconceptions of ART in order to reduce high risk sexual behaviors, especially among youth.

16 Article Characteristics of HIV-1 serodiscordant couples enrolled in a clinical trial of antiretroviral pre-exposure prophylaxis for HIV-1 prevention. 2011

Mujugira, Andrew / Baeten, Jared M / Donnell, Deborah / Ndase, Patrick / Mugo, Nelly R / Barnes, Linda / Campbell, James D / Wangisi, Jonathan / Tappero, Jordan W / Bukusi, Elizabeth / Cohen, Craig R / Katabira, Elly / Ronald, Allan / Tumwesigye, Elioda / Were, Edwin / Fife, Kenneth H / Kiarie, James / Farquhar, Carey / John-Stewart, Grace / Kidoguchi, Lara / Panteleeff, Dana / Krows, Meighan / Shah, Heena / Revall, Jennifer / Morrison, Susan / Ondrejcek, Lisa / Ingram, Charlotte / Coombs, Robert W / Lingappa, Jairam R / Celum, Connie / Anonymous5060707. ·Department of Global Health, University of Washington, Seattle, Washington, United States of America. ·PLoS One · Pubmed #21998703.

ABSTRACT: INTRODUCTION: Stable heterosexual HIV-1 serodiscordant couples in Africa have high HIV-1 transmission rates and are a critical population for evaluation of new HIV-1 prevention strategies. The Partners PrEP Study is a randomized, double-blind, placebo-controlled trial of tenofovir and emtricitabine-tenofovir pre-exposure prophylaxis to decrease HIV-1 acquisition within heterosexual HIV-1 serodiscordant couples. We describe the trial design and characteristics of the study cohort. METHODS: HIV-1 serodiscordant couples, in which the HIV-1 infected partner did not meet national guidelines for initiation of antiretroviral therapy, were enrolled at 9 research sites in Kenya and Uganda. The HIV-1 susceptible partner was randomized to daily oral tenofovir, emtricitabine-tenofovir, or matching placebo with monthly follow-up for 24-36 months. RESULTS: From July 2008 to November 2010, 7920 HIV-1 serodiscordant couples were screened and 4758 enrolled. For 62% (2966/4758) of enrolled couples, the HIV-1 susceptible partner was male. Median age was 33 years for HIV-1 susceptible and HIV-1 infected partners [IQR (28-40) and (26-39) respectively]. Most couples (98%) were married, with a median duration of partnership of 7.0 years (IQR 3.0-14.0) and recent knowledge of their serodiscordant status [median 0.4 years (IQR 0.1-2.0)]. During the month prior to enrollment, couples reported a median of 4 sex acts (IQR 2-8); 27% reported unprotected sex and 14% of male and 1% of female HIV-1 susceptible partners reported sex with outside partners. Among HIV-1 infected partners, the median plasma HIV-1 level was 3.94 log(10) copies/mL (IQR 3.31-4.53) and median CD4 count was 496 cells/µL (IQR 375-662); the majority (64%) had WHO stage 1 HIV-1 disease. CONCLUSIONS: Couples at high risk of HIV-1 transmission were rapidly recruited into the Partners PrEP Study, the largest efficacy trial of oral PrEP. (ClinicalTrials.gov NCT00557245).

17 Article Loop electrosurgical excision procedure: safety and tolerability among human immunodeficiency virus-positive Kenyan women. 2011

Woo, Victoria G / Cohen, Craig R / Bukusi, Elizabeth A / Huchko, Megan J. ·University of California San Francisco, San Francisco, California, USA. ·Obstet Gynecol · Pubmed #21860283.

ABSTRACT: OBJECTIVES: To estimate the safety, tolerability, and acceptability of loop electrosurgical excision procedure (LEEP) for cervical intraepithelial neoplasia (CIN 2 or 3) in human immunodeficiency virus (HIV)-positive women performed by nonphysician health care providers in an HIV care and treatment clinic. METHODS: We performed a prospective cohort study among women undergoing LEEP for biopsy-confirmed CIN 2 or 3 at the Family Acquired Immunodeficiency Syndrome Care and Education Services Clinic in Kisumu, Kenya. Women were followed-up 4 weeks after the procedure and questioned for abstinence as well as presence and severity of side effects after the procedure. The results were analyzed using descriptive statistics and univariable and multivariable analysis. RESULTS: Among the 180 (91%) women who returned for a 4-week follow up after LEEP, 52% reported at least one postprocedure symptom, including bleeding, discharge, or pain. Using a Likert scale for severity of symptoms, 179 (99%) reported very mild to mild symptoms, whereas one (1%) participant described the symptoms as moderate. No participants reported severe symptoms. Mean CD4 count was significantly higher among women who reported any symptoms compared with women who reported no symptoms after LEEP (419 cells/mm compared with 349 cells/mm, P<.05), an association that remained significant after adjustment for antiretroviral treatment. The presence or severity of postprocedure symptoms did not differ among women who reported sexual activity (16%) less than 4 weeks after the procedure. CONCLUSION: LEEP performed by clinical officers was well-accepted by HIV-positive women and appears safe, resulting in minimal side effects, even among women with early resumption of intercourse. LEVEL OF EVIDENCE: II.

18 Article Increased risk of HIV-1 transmission in pregnancy: a prospective study among African HIV-1-serodiscordant couples. 2011

Mugo, Nelly R / Heffron, Renee / Donnell, Deborah / Wald, Anna / Were, Edwin O / Rees, Helen / Celum, Connie / Kiarie, James N / Cohen, Craig R / Kayintekore, Kayitesi / Baeten, Jared M / Anonymous790701. ·Department of Obstetrics and Gynaecology, Kenyatta National Hospital, Nairobi, Kenya. rwamba@u.washington.edu ·AIDS · Pubmed #21785321.

ABSTRACT: BACKGROUND: Physiologic and behavioral changes during pregnancy may alter HIV-1 susceptibility and infectiousness. Prospective studies exploring pregnancy and HIV-1 acquisition risk in women have found inconsistent results. No study has explored the effect of pregnancy on HIV-1 transmission risk from HIV-1-infected women to male partners. METHODS: In a prospective study of African HIV-1-serodiscordant couples, we evaluated the relationship between pregnancy and the risk of HIV-1 acquisition among women and HIV-1 transmission from women to men. RESULTS: Three thousand three hundred and twenty-one HIV-1-serodiscordant couples were enrolled, 1085 (32.7%) with HIV-1 susceptible female partners and 2236 (67.3%) with susceptible male partners. HIV-1 incidence in women was 7.35 versus 3.01 per 100 person-years during pregnant and nonpregnant periods [hazard ratio 2.34, 95% confidence interval (CI) 1.33-4.09]. This effect was attenuated and not statistically significant after adjusting for sexual behavior and other confounding factors (adjusted hazard ratio 1.71, 95% CI 0.93-3.12). HIV-1 incidence in male partners of infected women was 3.46 versus 1.58 per 100 person-years when their partners were pregnant versus not pregnant (hazard ratio 2.31, 95% CI 1.22-4.39). This effect was not attenuated in adjusted analysis (adjusted hazard ratio 2.47, 95% CI 1.26-4.85). CONCLUSION: HIV-1 risk increased two-fold during pregnancy. Elevated risk of HIV-1 acquisition in pregnant women appeared in part to be explained by behavioral and other factors. This is the first study to show that pregnancy increased the risk of female-to-male HIV-1 transmission, which may reflect biological changes of pregnancy that could increase HIV-1 infectiousness.

19 Article Pregnancy and HIV transmission among HIV-discordant couples in a clinical trial in Kisumu, Kenya. 2011

Brubaker, S G / Bukusi, E A / Odoyo, J / Achando, J / Okumu, A / Cohen, C R. ·Department of Obstetrics, Gynecology and Reproductive Sciences, University of California, San Francisco, CA, USA. sara.brubaker@ucsf.edu ·HIV Med · Pubmed #21205129.

ABSTRACT: OBJECTIVES: A large proportion of new HIV infections in sub-Saharan Africa occur in stable HIV-discordant partnerships. In some couples, the strong desire to conceive a child may lead to risky behaviour despite knowledge of discordant serostatus. Our objective was to compare HIV transmission between discordant couples who did and did not conceive during participation in a clinical trial. METHODS: Five hundred and thirty-two HIV-discordant couples were followed for up to 2 years in Kisumu, Kenya as part of the Partners in Prevention HSV/HIV Transmission Study. Quarterly HIV-1 antibody and urine pregnancy test results were analysed. RESULTS: Forty-one HIV-1 seroconversions occurred over 888 person-years of follow-up, resulting in an annual incidence of 4.6/100 person-years. Twenty seroconversions occurred among 186 HIV-1-uninfected individuals in partnerships in which pregnancy occurred (10.8% of HIV-1-negative partners in this group seroconverted), in comparison to 21 seroconversions among 353 uninfected individuals in partnerships in which pregnancy did not occur (5.9% of HIV-1-negative partners seroconverted), resulting in a relative risk of 1.8 [95% confidence interval (CI) 1.01-3.26; P<0.05]. CONCLUSIONS: Pregnancy was associated with an increased risk of HIV seroconversion in discordant couples. These data suggest that the intention to conceive among HIV discordant couples may be contributing to the epidemic.