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Ndase P.,University of Washington | Celum C.,University of Washington | Campbell J.,Centers for Disease Control and Prevention | Bukusi E.,University of Washington | And 14 more authors.
Journal of Acquired Immune Deficiency Syndromes

Background: Dissemination of research results to study participants and stakeholders and provision of proven effective products in the immediate post-trial period are core elements of the conduct of biomedical HIV prevention clinical trials. Few biomedical HIV prevention trials have demonstrated HIV protection with novel interventions, and thus, communication of positive trial results and provision of an effective product have not been tested in many situations. Methods: In July 2011, the independent Data and Safety Monitoring Board of the Partners PrEP Study, a randomized, placebo-controlled efficacy trial of daily oral antiretroviral preexposure prophylaxis (PrEP) for HIV prevention among 4747 African heterosexual HIV serodiscordant couples, recommended discontinuation of the trial's placebo arm due to demonstration of PrEP efficacy. We describe dissemination of results, discontinuation of the placebo arm, and provision of active PrEP to participants' formerly assigned placebo. Results: Within 72 hours, of the Data and Safety Monitoring Board meeting the study results were publicly released and disseminated to stakeholders and study participants. Within 3 months, the study protocol was modified to permit participants initially assigned to the study's placebo arm to be offered active PrEP. Of the 1418 participants initially randomized to placebo who were clinically eligible to receive PrEP, 89.1% (1264/1418) consented. Conclusions: Prompt dissemination of a positive HIV prevention trial result and subsequent provision of effective product to research participants was feasible and efficient for >4700 HIV serodiscordant couples in East Africa. The extent to which study sponsors can assure continued product access to research participants remains a subject of discussion for future HIV prevention clinical trials. Copyright © 2014 by Lippincott Williams & Wilkins. Source

Mujugira A.,University of Washington | Celum C.,University of Washington | Thomas K.K.,University of Washington | Farquhar C.,University of Washington | And 7 more authors.
Journal of Acquired Immune Deficiency Syndromes

Objective:: WHO guidance recommends antiretroviral therapy (ART) initiation for all persons with a known HIV-uninfected partner, as a strategy to prevent HIV transmission. Uptake of ART among HIV-infected partners in serodiscordant partnerships is not known, which we evaluated in African HIV serodiscordant couples. Design:: Prospective cohort study. Methods:: Among HIV-infected persons from Kenya and Uganda who had a known heterosexual HIV-uninfected partner, we assessed ART initiation in those who became ART eligible under national guidelines during follow-up. Participants received quarterly clinical and semi-annual CD4 monitoring, and active referral for ART upon becoming eligible. Results:: Of 1958 HIV-infected ART-eligible partners, 58% were women, and the median age was 34 years. At the first visit when determined to be ART eligible, the median CD4 count was 273 cells per microliter (interquartile range, 221-330), 77% had WHO stage 1 or 2 HIV disease, and 96% were receiving trimethoprim-sulfamethoxazole prophylaxis. The cumulative probabilities of initiating ART at 6, 12, and 24 months after eligibility were 49.9%, 70.0%, and 87.6%, respectively. Younger age [<25 years; adjusted hazard ratio (AHR), 1.39; P = 0.001], higher CD4 count (AHR, 1.95; P < 0.001 for >350 compared with <200 cells/μL), higher education (AHR, 1.25; P < 0.001), and lack of income (AHR, 1.15; P = 0.02) were independent predictors for delay in ART initiation. Conclusions:: In the context of close CD4 monitoring, ART counseling, and active linkage to HIV care, a substantial proportion of HIV-infected persons with a known HIV-uninfected partner delayed ART initiation. Strategies to motivate ART initiation are needed, particularly for younger persons with higher CD4 counts. Copyright © 2014 by Lippincott Williams & Wilkins. Source

Asiimwe S.,University of Georgia | Asiimwe S.,Kabwohe Clinical Research Center | Oloya J.,University of Georgia | Song X.,University of Georgia | Whalen C.C.,University of Georgia
AIDS and Behavior

Unsupervised HIV self-testing (HST) has potential to increase knowledge of HIV status; however, its accuracy is unknown. To estimate the accuracy of unsupervised HST in field settings in Uganda, we performed a non-blinded, randomized controlled, non-inferiority trial of unsupervised compared with supervised HST among selected high HIV risk fisherfolk (22.1 % HIV Prevalence) in three fishing villages in Uganda between July and September 2013. The study enrolled 246 participants and randomized them in a 1:1 ratio to unsupervised HST or provider-supervised HST. In an intent-to-treat analysis, the HST sensitivity was 90 % in the unsupervised arm and 100 % among the provider-supervised, yielding a difference 0f -10 % (90 % CI -21, 1 %); non-inferiority was not shown. In a per protocol analysis, the difference in sensitivity was -5.6 % (90 % CI -14.4, 3.3 %) and did show non-inferiority. We conclude that unsupervised HST is feasible in rural Africa and may be non-inferior to provider-supervised HST. © 2014 Springer Science+Business Media New York. Source

Haberer J.E.,Massachusetts General Hospital | Haberer J.E.,Harvard University | Baeten J.M.,University of Washington | Campbell J.,Centers for Disease Control and Prevention | And 18 more authors.
PLoS Medicine

Background:Randomized clinical trials of oral antiretroviral pre-exposure prophylaxis (PrEP) for HIV prevention have widely divergent efficacy estimates, ranging from 0% to 75%. These discrepancies are likely due to differences in adherence. To our knowledge, no studies to date have examined the impact of improving adherence through monitoring and/or intervention, which may increase PrEP efficacy, or reported on objective behavioral measures of adherence, which can inform PrEP effectiveness and implementation.Methods and Findings:Within the Partners PrEP Study (a randomized placebo-controlled trial of oral tenofovir and emtricitabine/tenofovir among HIV-uninfected members of serodiscordant couples in Kenya and Uganda), we collected objective measures of PrEP adherence using unannounced home-based pill counts and electronic pill bottle monitoring. Participants received individual and couples-based adherence counseling at PrEP initiation and throughout the study; counseling was intensified if unannounced pill count adherence fell to <80%. Participants were followed monthly to provide study medication, adherence counseling, and HIV testing. A total of 1,147 HIV-uninfected participants were enrolled: 53% were male, median age was 34 years, and median partnership duration was 8.5 years. Fourteen HIV infections occurred among adherence study participants-all of whom were assigned to placebo (PrEP efficacy = 100%, 95% confidence interval 83.7%-100%, p<0.001). Median adherence was 99.1% (interquartile range [IQR] 96.9%-100%) by unannounced pill counts and 97.2% (90.6%-100%) by electronic monitoring over 807 person-years. Report of no sex or sex with another person besides the study partner, younger age, and heavy alcohol use were associated with <80% adherence; the first 6 months of PrEP use and polygamous marriage were associated with >80% adherence. Study limitations include potential shortcomings of the adherence measures and use of a convenience sample within the substudy cohort.Conclusions:The high PrEP adherence achieved in the setting of active adherence monitoring and counseling support was associated with a high degree of protection from HIV acquisition by the HIV-uninfected partner in heterosexual serodiscordant couples. Low PrEP adherence was associated with sexual behavior, alcohol use, younger age, and length of PrEP use.Please see later in the article for the Editors' Summary. © 2013 Haberer et al. Source

Nanvubya A.,UVRI IAVI HIV Vaccine Program | Ssempiira J.,UVRI IAVI HIV Vaccine Program | Mpendo J.,UVRI IAVI HIV Vaccine Program | Ssetaala A.,UVRI IAVI HIV Vaccine Program | And 10 more authors.

Introduction: Fishing communities (FCs) in Uganda have high HIV infection rates but poor access to health services including family planning (FP). Although FP is a cost-effective public health intervention, there is a paucity of data on knowledge and use of modern FP in FCs. This study determined knowledge and use of modern FP methods in FCs of Uganda. Methods: Data were accrued from a 12-month follow up of 1,688 HIV-uninfected individuals, 18-49 years from 8 FCs along Lake Victoria, between September 2011 and March 2013. Data on knowledge and use of modern FP were collected through a semi-structured questionnaire. Prevalence Risk Ratios with corresponding 95% CIs were used to determine factors associated with Modern FP knowledge and use. Results: The mean age was 31.4 years, with nearly half (48.8%) being females while more than half (58.6%) had attained up to primary education level. Knowledge of modern FP was high, 87.5% (1477/1688); significantly higher among females [adj. PRR = 4.84 (95% CI; 3.08, 7.61)], among older respondents (25-29 years) [adj. PRR = 1.83 (95% CI; 1.12, 2.99)] compared to younger ones (18-24 years) and among those conducting business [adj. PRR = 2.42(95% CI; 1.02, 5.74)] relative to those primarily in fishing. Just over a third (35.2%, 595/1688) reported use of at least one modern FP method. Use of modern FP methods was significantly higher among females [adj. PRR = 2.04 (95% CI; 1.56, 2.65, and among those reporting multiple sexual partnerships [adj. PRR = 2.12, 95% CI; 1.63, 2.76)]. Nonuse of modern methods was mostly due to desire for more children (30.6%), fear of side effects (12.2%) and partner refusal (5.2%). Conclusion: Despite their high knowledge of FP, FCs have low use of modern FP methods. Key barriers to use of modern FP methods were high fertility desires, fear of perceived side effects and partner refusal of methods. © 2015 Nanvubya et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Source

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