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No Evidence of Sexual Risk Compensation Following PrEP Initiation Among Heterosexual HIV Serodiscordant Couples in Kenya and Uganda.

ABSTRACT: Recent studies among men who have sex with men suggest that sexual behaviors associated with risk of sexually transmitted infections increase following initiation of pre-exposure prophylaxis (PrEP) for HIV prevention. We used longitudinal data from HIV-uninfected participants (n?=?1013) enrolled in an open-label study of PrEP delivered to Ugandan and Kenyan heterosexual HIV serodiscordant couples to understand the association between PrEP initiation and HIV risk-related sexual behaviors among these couples. In the month following PrEP initiation, the mean number of monthly sex acts within couples decreased from 7.9 to 6.9 (mean difference: - 1.1; 95% CI - 1.5, - 0.7) and the proportion of couples having condomless sex decreased from 65% to 32% (percentage point change: - 33%; 95% CI - 37%, - 30%); these behaviors then remained relatively constant over 2 years. We found no evidence of sexual risk compensation following PrEP initiation within African serodiscordant couples. However, roughly a third of couples continued to engage in condomless sex during follow up, emphasizing the importance of continued PrEP use to sustain HIV protection.

SUBMITTER: Ortblad KF

PROVIDER: S-EPMC7156350 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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No Evidence of Sexual Risk Compensation Following PrEP Initiation Among Heterosexual HIV Serodiscordant Couples in Kenya and Uganda.

Ortblad Katrina F KF Stalter Randy M RM Bukusi Elizabeth A EA Ngure Kenneth K Mujugura Andrew A Celum Connie C Baeten Jared M JM Heffron Renee R

AIDS and behavior 20200501 5

Recent studies among men who have sex with men suggest that sexual behaviors associated with risk of sexually transmitted infections increase following initiation of pre-exposure prophylaxis (PrEP) for HIV prevention. We used longitudinal data from HIV-uninfected participants (n = 1013) enrolled in an open-label study of PrEP delivered to Ugandan and Kenyan heterosexual HIV serodiscordant couples to understand the association between PrEP initiation and HIV risk-related sexual behaviors among th ...[more]

PMID: 31696370

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Project description:BackgroundIn 2016, the Kenyan Ministry of Health (MOH) released guidelines that recommend preexposure prophylaxis (PrEP) for persons with substantial ongoing HIV risk, including those in HIV serodiscordant partnerships. Estimates of the costs of delivering PrEP within Kenyan public health facilities are needed for planning for PrEP scale up.MethodsWe estimated the incremental annual costs of providing PrEP to HIV uninfected partners as a time-limited "bridge" until the infected partner is virally suppressed on ART within HIV serodiscordant couples as part of routine clinic care in Thika, Kenya. Costs were collected from the Partners Demonstration Project, a prospective evaluation of integrated delivery of preexposure prophylaxis (PrEP) and antiretroviral therapy (ART) to high-risk HIV serodiscordant couples. We conducted time and motion studies to distinguish between activities related to research, routine clinical care, and PrEP delivery. Costs (2015 US dollars) were collected from the MOH perspective and divided into staff, transportation, equipment, supplies, buildings and overhead, and start-up.ResultsPrEP related activities conducted during the screening, enrollment, and follow-up visits took an average of 13 minutes, 51 minutes, and 12 minutes, respectively. Assuming a staff structure of 3 counselors, 1 nurse, and 2 clinicians, we estimate that 3,178 couples can be screened, 1,444 couples offered PrEP and ART, and 6,138 couples followed up annually in an average HIV care clinic. Using costs incurred by the MOH for personnel, drug, and laboratory tests, we estimate that the incremental cost of offering PrEP to HIV uninfected partners within existing ART programs is $86.79 per couple per year. Personnel and PrEP medication made up the largest portion of the costs. We estimate that the total cost to Ministry of Health of delivering integrated PrEP and ART program in public health facilities is $250.19 per HIV serodiscordant couple per year.ConclusionsTime-limited provision of PrEP to the HIV uninfected partner within HIV serodiscordant couples can be an affordable delivery model implemented in HIV care programs in Kenya and similar settings. These costs can be used for budgetary planning and cost effectiveness analyses.

Project description:BACKGROUND:Antiretroviral-based interventions for HIV-1 prevention, including antiretroviral therapy (ART) to reduce the infectiousness of HIV-1 infected persons and pre-exposure prophylaxis (PrEP) to reduce the susceptibility of HIV-1 uninfected persons, showed high efficacy for HIV-1 protection in randomized clinical trials. We conducted a prospective implementation study to understand the feasibility and effectiveness of these interventions in delivery settings. METHODS AND FINDINGS:Between November 5, 2012, and January 5, 2015, we enrolled and followed 1,013 heterosexual HIV-1-serodiscordant couples in Kenya and Uganda in a prospective implementation study. ART and PrEP were offered through a pragmatic strategy, with ART promoted for all couples and PrEP offered until 6 mo after ART initiation by the HIV-1 infected partner, permitting time to achieve virologic suppression. One thousand thirteen couples were enrolled, 78% of partnerships initiated ART, and 97% used PrEP, during a median follow-up of 0.9 years. Objective measures of adherence to both prevention strategies demonstrated high use (?85%). Given the low HIV-1 incidence observed in the study, an additional analysis was added to compare observed incidence to incidence estimated under a simulated counterfactual model constructed using data from a prior prospective study of HIV-1-serodiscordant couples. Counterfactual simulations predicted 39.7 HIV-1 infections would be expected in the population at an incidence of 5.2 per 100 person-years (95% CI 3.7-6.9). However, only two incident HIV-1 infections were observed, at an incidence of 0.2 per 100 person-years (95% CI 0.0-0.9, p < 0.0001 versus predicted). The use of a non-concurrent comparison of HIV-1 incidence is a potential limitation of this approach; however, it would not have been ethical to enroll a contemporaneous population not provided access to ART and PrEP. CONCLUSIONS:Integrated delivery of time-limited PrEP until sustained ART use in African HIV-1-serodiscordant couples was feasible, demonstrated high uptake and adherence, and resulted in near elimination of HIV-1 transmission, with an observed HIV incidence of <0.5% per year compared to an expected incidence of >5% per year.

Project description:IntroductionPre-exposure prophylaxis (PrEP) to prevent HIV infection is being rolled out in Africa. The uptake of PrEP to date has varied across populations and locations. We seek to understand the drivers of demand for PrEP through analysis of qualitative data collected in conjunction with a PrEP demonstration project involving East African HIV serodiscordant couples. Our goal was to inform demand creation by understanding what PrEP means - beyond HIV prevention - for the lives of users.MethodsThe Partners Demonstration Project evaluated an integrated strategy of PrEP and antiretroviral therapy (ART) delivery in which time-limited PrEP served as a "bridge" to long-term ART. Uninfected partners in HIV serodiscordant couples were offered PrEP at baseline and encouraged to discontinue once infected partners had taken ART for six months. We conducted 274 open-ended interviews with 93 couples at two Ugandan research sites. Interviews took place one month after enrolment and at later points in the follow-up period. Topics included are as follows: (1) discovery of serodiscordance; (2) decisions to accept/decline PrEP and/or ART; (3) PrEP and ART initiation; (4) experiences of using PrEP and ART; (5) PrEP discontinuation; (6) impact of PrEP and ART on the partnered relationship. Interviews were audio-recorded and transcribed. We used an inductive, content analytic approach to characterize meanings of PrEP stemming from its effectiveness for HIV prevention. Relevant content was represented as descriptive categories.ResultsDiscovery of HIV serodiscordance resulted in fear of HIV transmission for couples, which led to loss of sexual intimacy in committed relationships, and to abandonment of plans for children. As a result, partners became alienated from each other. PrEP countered the threat to the relationship by reducing fear and reinstating hopes of having children together. Condom use worked against the re-establishment of intimacy and closeness. By increasing couples' sense of protection against HIV infection and raising the prospect of a return to "live sex" (sex without condoms), PrEP was perceived by couples as solving the problem of serodiscordance and preserving committed relationships.ConclusionsThe most effective demand creation strategies for PrEP may be those that address the everyday life priorities of potential users in addition to HIV prevention.Clinical trial numberNCT02775929.

Project description:INTRODUCTION:Sexual quality of life (SQoL) is a critical component of sexual health and is understudied in Sub-Saharan African settings with endemic HIV and sexually transmitted infection (STI). AIM:We sought to assess SQoL among heterosexual couples in Kisumu, Kenya, and how this was associated with HIV status, STIs, and sexual practices. METHODS:This was a prospective cohort study of community-recruited couples. SQoL, HIV status, herpes simplex virus (HSV)-2 status, bacterial vaginosis (BV), sexual practices, and sociodemographics were measured at baseline, 6 months, and 12 months. Multivariable linear regression with random intercept was fitted separately for females and males, accounting for partner characteristics. MAIN OUTCOME MEASURE:SQoL was assessed with an 18-item female and 11-item male survey. RESULTS:From April 2014 through July 2016, 252 couples were enrolled, and followed up through September 2017. At baseline, women were median age 23 years, 10% HIV positive, 53% HSV-2 seropositive, and 22% with BV. At baseline men were median age 26 years, 12% HIV positive, 47% HSV-2 seropositive, and 56% circumcised. Mean SQoL was higher for men (88) than women (78), with consistent scores over time. In multivariable analysis (P < .05 each), SQoL Questionnaire-Female (SQoL-F) score was reduced with: male partner report that sex felt rougher than he would have liked (9.5-point decrease), female HSV-2 seropositivity (5.15-point decrease), female reported having dry vaginal sex (5.27-point decrease); among women with BV, SQoL-F score declined with recent sexual activity (8.27-point decrease) and increasing age (0.75-point decrease per 1 year increase in age). Age and recent sex did not affect SQoL-F for women without BV. SQoL Questionnaire-Male score was decreased 4.99 points if male was employed, 4.52 points if male reported multiple recent sex partners, and 29.5 points for HIV positive men whose female partner reported having sex when not in the mood. Men's SQoL increased by 0.84 points for each 1-U increase in female partner body mass index and 17.6 points for HIV positive men whose female partner reported recent sex with him. CLINICAL IMPLICATIONS:Within sexual partnerships, men had greater SQoL than women, and the adverse impact of BV and STIs on SQoL was greater for women than men. STRENGTH & LIMITATIONS:Research is needed to ensure relevant domains are measured in settings where measure of SQoL has not been validated, along with robust measures of physiologic and psychologic correlates. CONCLUSION:More attention to SQoL as an outcome may strengthen interventions aimed at preventing HIV and STIs and improving sexual health holistically. Mehta SD, Nordgren RK, Agingu W, et al. Sexual Quality of Life and Association With HIV and Sexually Transmitted Infections Among a Cohort of Heterosexual Couples in Kenya. J Sex Med 2018;15:1446-1455.

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No Evidence of Sexual Risk Compensation Following PrEP Initiation Among Heterosexual HIV Serodiscordant Couples in Kenya and Uganda.

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No Evidence of Sexual Risk Compensation Following PrEP Initiation Among Heterosexual HIV Serodiscordant Couples in Kenya and Uganda.

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