Trial reportPloS one2025
Evaluation of a combination adherence strategy to support HIV antiretroviral therapy for pregnancy and breastfeeding in Malawi: A pilot randomized clinical trial.
Trial report in PloS one, 2025. 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 2 papers.
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.
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
2 citing papers in PubMed.
- Uptake and retention in HIV care among pregnant and postpartum women living with HIV under different eras of vertical transmission prevention policies in sub-Saharan Africa: a systematic review and meta-analysis.medRxiv : the preprint server for health sciences · 2026Article
- Global, regional, and national burden and trends of HIV/AIDS among women of childbearing age from 1990 to 2021: results from Global Burden of Disease 2021.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
Abstract
backgroundThere has been tremendous progress in reducing vertical transmission of HIV in the past two decades due to the broad availability of antiretroviral therapy (ART) globally. Despite this progress, new paediatric infections are still occurring.
methodsIn a pilot study, we evaluated a combination adherence support package, which included an adapted motivational interviewing-informed counselling approach (Integrated Next Step Counselling, iNSC) and an optional adherence supporter, for pregnant and breastfeeding women living with HIV. Participants were recruited from the antenatal clinic in Lilongwe, Malawi. Eligible participants were randomly allocated 1:1 to receive either the combination adherence package (intervention) or standard care (control) at the health facility. Our clinical outcome, measured at three- and six-month follow-up, was a composite endpoint of study retention with HIV viral suppression (HIV RNA <40 copies per mL).
resultsWe screened 106 women living with HIV between March and July 2020. Of these, 100 women enrolled and were randomly assigned to intervention (n=51) or control (n=49). The majority of participants (94 of 100; 94%) were newly diagnosed with HIV. Retention in care was 92% at three months and 84% at six months. Three-quarters of women retained in care were virally suppressed at the three- and six-month study visits. At three months, our composite outcome (retention & viral suppression) was achieved by 70.6% (36/51) and 69.4% (34/49) of women in the intervention and control groups, respectively. At six months, this composite outcome was achieved by 68.6% (35/51) of the intervention group and 61.2% (30/49) of the control group (probability difference: 7.4%, 95% CI: -11.3%, 26.1%).
conclusionThese encouraging pilot findings suggest that this combination adherence package could be used to support ART adherence among pregnant and breastfeeding women living with HIV. We demonstrate feasibility of using a combined measure of adherence and viral suppression as an outcome measure.
trial registrationClinicalTrials.gov (NCT04330989).
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