ArticlePloS one2022
Adaptive HIV pre-exposure prophylaxis adherence interventions for young South African women: Study protocol for a sequential multiple assignment randomized trial.
Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04038060 (Evaluation of Stepped PrEP), which is not on this map. Cited by 14 papers, 1 of them a synthesis 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.
Evaluation of Stepped PrEP (Pre-exposure Prophylaxis) Adherence Support for Young South African Women Using a SMART Design
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Individualized interventions and precision health: Lessons learned from a systematic review and implications for analytics-driven geriatric research.Journal of the American Geriatrics Society · 2023Pooled it
- Impact of a point-of-care urine tenofovir assay on adherence to HIV pre-exposure prophylaxis among women in Kenya: a randomised pilot trial.The lancet. HIV · 2024Trial
- Commonality and co-occurrence of discrete strategies within implementation strategy bundles: findings from the Living Database of HIV Implementation Science systematic review, 2014-2021.Implementation science communications · 2026Review
- A review of use of external data and update on reporting standards in Sequential Multiple-Assignment Randomised Trials.Clinical trials (London, England) · 2026Review
- Exploring the role of group support models for HIV prevention among adolescent girls and young women (AGYW) in sub-Saharan Africa (SSA): a scoping review.Frontiers in reproductive health · 2026Review
- Acceptability and Feasibility of Remote PrEP Visits for Adolescent Girls and Young Women in South Africa.AIDS and behavior · 2025Article
- Mobile Health Intervention Tools Promoting HIV Pre-Exposure Prophylaxis Among Adolescent Girls and Young Women in Sub-Saharan Africa: Scoping Review.JMIR mHealth and uHealth · 2025Article
- The impact of adherence counseling incorporating a point of care urine tenofovir assay on virologic suppression among individuals failing tenofovir-lamivudine-dolutegravir: A pre-post intervention study.International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases · 2025Article
- Integrating a mental health intervention into PrEP services for South African young women: a human-centred implementation research approach to intervention development.Journal of the International AIDS Society · 2024Article
- Point-of-care urine tenofovir monitoring of adherence to drive interventions for HIV treatment and prevention.Expert review of molecular diagnostics · 2024Review
- Factors that influence adolescent girls and young women's re-initiation or complete discontinuation from daily oral PrEP use: a qualitative study from Eastern Cape Province, South Africa.Journal of the International AIDS Society · 2023Article
- High PrEP uptake and objective longitudinal adherence among HIV-exposed women with personal or partner plans for pregnancy in rural Uganda: A cohort study.PLoS medicine · 2023Article
- Optimizing adaptive stepped-care interventions to change adults' health behaviors: A systematic review.Journal of clinical and translational science · 2023Review
- Improving HIV pre-exposure prophylaxis persistence among adolescent girls and young women: Insights from a mixed-methods evaluation of community, hybrid, and facility service delivery models in Namibia.Frontiers in reproductive health · 2022Article
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
introductionPre-exposure prophylaxis (PrEP) is a highly effective HIV prevention strategy and is recommended for populations at risk of HIV, including adolescent girls and young women (AGYW) in HIV endemic settings. However, PrEP continuation and high adherence remain challenges to its impact. Existing PrEP adherence interventions can be time- and cost-intensive. Widescale PrEP delivery will require the identification of layered PrEP support strategies for AGYW with diverse prevention needs. We describe the design of a sequential multiple assignment randomized trial (SMART) to evaluate a PrEP adherence support model using scalable, stepped interventions in AGYW in South Africa.
methods"PrEP SMART" is a randomized trial in Johannesburg, South Africa, enrolling AGYW who are between 18 and 25 years of age, sexually active, newly initiating PrEP, and have regular access to a mobile phone. Participants are randomized 1:1 to standard-of-care PrEP counseling with either two-way SMS or WhatsApp group adherence support. Adherence is assessed at three months using tenofovir diphosphate (TFV-DP) levels from dried blood spots collected at month 2 to categorize participants as "responders" (TFV-DP ≥500 fmol/punch) or "non-responders" (TFV-DP <500 fmol/punch). AGYW defined as 'non-responders' undergo a secondary 1:1 randomization to either quarterly drug-level feedback counseling or monthly issue-focused counseling, in addition to their first-level intervention. The primary outcome is PrEP adherence at nine months (TFV-DP ≥700 fmol/punch). We will assess the effect of our two initial interventions on TFV-DP levels among responders, assess the effect of our intensified interventions on TFV-DP levels among non-responders, and identify the optimal sequence of adherence interventions through nine months.
trial registrationClinicalTrials.gov, NCT04038060. Registered on 30 July 2019.
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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.