ArticleBMJ open2021
Combination adherence strategy to support HIV antiretroviral therapy and pre-exposure prophylaxis adherence during pregnancy and breastfeeding: protocol for a pair of pilot randomised trials.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04330989 (UNCPMZ 41901 - An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women), which is not on this map. Cited by 12 papers.
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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.
UNCPMZ 41901 - An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women: a Pilot Study
Who cites it
12 citing papers in PubMed, 14 citations in OpenAlex.
- Trial
- Understanding the Influence of PrEP Motivations and Concerns on PrEP Use Among Pregnant Women in Lilongwe, Malawi: A Mixed-Methods Study.AIDS and behavior · 2026Article
- Weaving the Net: The Interplay of Micro- and Macrosupport in ART Adherence.AIDS research and treatment · 2026Article
- Assessing the Implementation Fidelity of a Patient-Centered, Combination Adherence Strategy to Support HIV Antiretroviral Therapy and Pre-Exposure Prophylaxis Adherence During Pregnancy and Breastfeeding in Malawi.AIDS and behavior · 2025Article
- Effect of initiation of antiretroviral drugs for HIV prevention or treatment on the vaginal microbiome of pregnant women in Malawi.NPJ biofilms and microbiomes · 2025Article
- Understanding PrEP misconceptions and their impact on PrEP initiation and use among pregnant and lactating women in Malawi.PLOS global public health · 2025Article
- Alignment of PrEP adherence and HIV exposure risk among pregnant and postpartum women in Lilongwe, Malawi.PloS one · 2025Article
- Combination HIV prevention during pregnancy and the post-partum period in Malawi and Zambia: a mathematical modelling analysis.Journal of the International AIDS Society · 2023Article
- Male partners' support and influence on pregnant women's oral PrEP use and adherence in Malawi.Frontiers in reproductive health · 2023Article
- Article
- Understanding PrEP decision making among pregnant women in Lilongwe, Malawi: A mixed-methods study.Journal of the International AIDS Society · 2022Article
- A pilot randomized controlled trial ofWomen's health (London, England)Article
Corrections and comments
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Authors and funding
15 authors at 5 institutions in 4 countries.
Funding
Abstract
introductionTo realise the expected gains from prevention of mother-to-child HIV transmission initiatives, adherence to preventative and therapeutic antiretroviral regimens is critical and interventions deployable in busy programmatic settings with a high HIV burden are needed. Based on formative research, we developed an approach that integrates patient-centred counselling and engagement of an adherence supporter for pregnant and breastfeeding women initiating HIV treatment (ie, antiretroviral therapy (ART)) or biomedical HIV prevention (ie, pre-exposure prophylaxis (PrEP)).
methodsTonse Pamodzi 2 is a pilot study designed to provide acceptability, fidelity and clinical outcomes data on a set of behavioural interventions for adherence support. The study comprises two parallel randomised trials, enrolling HIV-positive pregnant women initiating ART (Trial 1, n=100) and HIV-negative pregnant women with risk of HIV acquisition and willing to initiate PrEP (Trial 2, n=200). Within each trial, participants are randomised 1:1 to either the intervention or control group. The Tonse Pamodzi adherence intervention comprises patient-centred counselling (adapted Integrated Next Step Counseling(iNSC)) and external adherence support tailored to the clinical context (ie, for ART or PrEP). Participants randomly assigned to the control group receive standard counselling based on local HIV guidelines. Participants are followed for 6 months. To assess intervention acceptability, we will employ a mixed method approach to describe participant engagement, satisfaction, and discussion content. We will audit and score recorded counselling sessions to evaluate the implementation fidelity of iNSC sessions. We will also assess clinical outcomes at 3 and 6 months for both Trial 1 (retention in care and viral suppression of HIV) and Trial 2 (retention in care, and plasma and intracellular tenofovir drug concentrations). ETHICS AND DISSEMINATION: The study protocol was approved by the Malawi National Health Science Research Committee (19/05/2334) and the University of North Carolina at Chapel Hill Institutional Review Board (19-1060). TRIAL REGISTRATION NUMBER: NCT04330989.
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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.