ArticlePLoS medicine2016
Integrated Delivery of Antiretroviral Treatment and Pre-exposure Prophylaxis to HIV-1-Serodiscordant Couples: A Prospective Implementation Study in Kenya and Uganda.
Article in PLoS medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03030768 (Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples), which is not on this map. Cited by 146 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pilot of an mHealth-enhanced, Safer Conception Intervention to Reduce HIV-1 Risk Among Kenyan HIV-1 Serodiscordant Couples
Who cites it
146 citing papers in PubMed, 3 syntheses or guidelines pooled it, 212 citations in OpenAlex.
- Quantitative Methods Used to Evaluate Impact of Combination HIV Prevention Intervention: A Methodological Systematic Review.AIDS and behavior · 2023Pooled it
- Oral preexposure prophylaxis continuation, measurement and reporting.AIDS (London, England) · 2020Pooled it
- Canadian guideline on HIV pre-exposure prophylaxis and nonoccupational postexposure prophylaxis.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2017Guideline
- Trial
- Acceptability and feasibility of a urine-based tenofovir adherence assay for monitoring and providing feedback on PrEP adherence in Kenya.AIDS care · 2025Trial
- Evaluation of pharmacokinetics of Tenofovir Alafenamide (TAF) and Tenofovir Disoproxil (TDF) in pregnant and postpartum women in South Africa: PrEP-PP PK study.Antiviral research · 2024Trial
- Trial
- Patterns of PrEP continuation and coverage in the first year of use: a latent class analysis of a programmatic PrEP trial in Kenya.Journal of the International AIDS Society · 2023Trial
- The cost of implementing the Systems Analysis and Improvement Approach for a cluster randomized trial integrating HIV testing into family planning services in Mombasa County, Kenya.BMC health services research · 2022Trial
- High HIV incidence among young women in South Africa: Data from a large prospective study.PloS one · 2022Trial
- Integration of pre-exposure prophylaxis services into public HIV care clinics in Kenya: a pragmatic stepped-wedge randomised trial.The Lancet. Global health · 2021Trial
- Using the adherence-efficacy relationship of emtricitabine and tenofovir disoproxil fumarate to calculate background hiv incidence: a secondary analysis of a randomized, controlled trial.Journal of the International AIDS Society · 2021Trial
- Altered Antibody Responses in Persons Infected with HIV-1 While Using Preexposure Prophylaxis.AIDS research and human retroviruses · 2021Trial
- Safety, uptake, and use of a dapivirine vaginal ring for HIV-1 prevention in African women (HOPE): an open-label, extension study.The lancet. HIV · 2021Trial
- Impact of Male Partner Involvement on Women's Adherence to the Dapivirine Vaginal Ring During a Phase III HIV Prevention Trial.AIDS and behavior · 2020Trial
- Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT.Journal of acquired immune deficiency syndromes (1999) · 2019Trial
- Integrated provision of topical pre-exposure prophylaxis in routine family planning services in South Africa: a non-inferiority randomized controlled trial.Journal of the International AIDS Society · 2019Trial
- Distance to clinic is a barrier to PrEP uptake and visit attendance in a community in rural Uganda.Journal of the International AIDS Society · 2019Trial
- Early Adopters of Human Immunodeficiency Virus Preexposure Prophylaxis in a Population-based Combination Prevention Study in Rural Kenya and Uganda.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Trial
- Scale up of PrEP integrated in public health HIV care clinics: a protocol for a stepped-wedge cluster-randomized rollout in Kenya.Implementation science : IS · 2018Trial
86 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
23 authors at 8 institutions in 3 countries.
Funding
Abstract
backgroundAntiretroviral-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
findingsBetween 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.
conclusionsIntegrated 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.