Evidence map›Paper›PMID 41251867›Full record

Trial reportAIDS and behavior2026

A Dual Prevention Pill for HIV & Pregnancy Prevention: A Pilot Study Among Adolescent Girls and Young Women in Zimbabwe.

Nyaradzo M Mgodi, J Brady Burnett-Zieman, Caroline Murombedzi, Adlight Dandadzi, Vanessa Gatsi, Petina Musara, Sheu Matimbira, Gamuchirai Mavemwa, Jane Jambaya, Tinashe Chidemo and 5 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in AIDS and behavior, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04778514 (A Randomized, Crossover Study Comparing Adherence, Preference + Acceptability of a Dual Prevention Pill), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT04778514 nacompletednot on this map

A Randomized, Crossover Study Comparing Adherence, Preference + Acceptability of a Dual Prevention Pill (DPP) Capsule Containing PrEP + an Oral Contraceptive Versus Two Separate Pills in Women at Risk of HIV in Harare, Zimbabwe

TypeinterventionalSponsorPopulation CouncilRan2022 to 2023Enrolled30ConditionsHIV Infections, ContraceptionArmsDual Prevention Pill, PrEP and combined oral contraceptive (COC) as two separate tablets
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. SAHARA J : journal of Social Aspects of HIV/AIDS Research Alliance · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Nyaradzo M Mgodi *Faculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe. nmgodi@uz-ctrc.org.ORCID http://orcid.org/0000-0002-3085-5259
J Brady Burnett-ZiemanPopulation Council, Center for Biomedical Research, New York, NY, USA.
Caroline MurombedziFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.ORCID http://orcid.org/0000-0002-7032-2318
Adlight DandadziFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
Vanessa GatsiFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
Petina MusaraFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.ORCID http://orcid.org/0000-0001-9668-4344
Sheu MatimbiraFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
Gamuchirai MavemwaFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
Jane JambayaFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
Tinashe ChidemoFaculty of Medicine and Heath Sciences, Clinical Trials Research Centre, University of Zimbabwe, 15 Phillips Avenue, Belgravia, Harare, Zimbabwe.
Marlena PlagianosPopulation Council, Center for Biomedical Research, New York, NY, USA.
Lisa B HaddadPopulation Council, Center for Biomedical Research, New York, NY, USA.ORCID http://orcid.org/0000-0002-7631-6760
Irene V BrucePopulation Council, Center for Biomedical Research, New York, NY, USA.
Sanyukta MathurPopulation Council, Washington, DC, USA.ORCID http://orcid.org/0000-0003-1645-6734
Barbara A Friedland *Population Council, Center for Biomedical Research, New York, NY, USA.ORCID http://orcid.org/0000-0002-5041-3634

Funding

Combining PrEP with contraception: a pilot test of an intervention to increase adherence to PrEP in adolescent girls and young women in ZimbabweR34MH119982 · NIMH · POPULATION COUNCIL · PI FRIEDLAND, BARBARA A, MATHUR, SANYUKTA · 2019 to 2023
$900k
Children's Investment Fund Foundation 1903-03681 and 2106-06589NIMH NIH HHS R34MH119982
6 · The paper itself

Abstract

Adolescent girls and young women (AGYW) in sub-Saharan Africa are at risk for HIV/unintended pregnancy. Adherence and continuation to effective oral pre-exposure prophylaxis (PrEP) are limited in AGYW. We hypothesized that an over-encapsulated dual prevention pill (DPP) combining PrEP + oral contraceptive (OC) would be preferred, acceptable, and improve adherence compared to PrEP alone. We randomized HIV-uninfected, 16-24 year-olds 1:1 to use DPP or 2-pill regimen (2PR -PrEP and OCs separately) for three 28-day cycles each. We compared preference for DPP vs. 2PR (exact binomial test) and regimen effects on four acceptability domains: use attributes, product attributes, side effects, impact on sex (Wilcoxon signed-rank tests). Adherence was compared by regimen and sequence (mixed-effects logistic regression) using self-report, pill-count, tenofovir-diphosphate levels in dried blood spots (DBS), indicating ≥ 4 doses per week(≥ 500 fmol/punch at Month 1 and ≥ 700 fmol/punch at Months 2-6). 26/30 participants (mean age 19.4years) completed the study (Nov 2022-Sept 2023). 62% preferred DPP, 38% 2PR (p = 0.24). Most rated both regimens as acceptable, with no differences between them (all p > 0.05). Adherence was high by self-report (98%) and pill-count (97%), but low based on DBS results (DPP: mean 392 fmol/punch, 2PR: mean 384 fmol/punch); with only 10% consistently adherent. There was no difference in adherence by regimen, though odds were higher in period 1 vs. 2 (AOR 3.7; 95% CI 1.10-12.8). Both regimens were safe; 2 pregnancies occurred during the DPP regimen, with no HIV seroconversions. No significant differences in preference, acceptability, and adherence between DPP and 2PR were found in this study. Adherence was low and waned over time. A larger study with a smaller co-formulated DPP may better inform its impact on HIV and pregnancy prevention.The study has been registered at ClinicalTrials.gov Identifier NCT04778514.

Indexed as

Anti-HIV AgentsHIV InfectionsPre-Exposure ProphylaxisAdenineAdolescentFemaleHumansMedication AdherenceOrganophosphatesPilot ProjectsPregnancyTenofovirYoung AdultZimbabweAdenineAnti-HIV AgentsOrganophosphatesTenofovirtenofovir diphosphateAdolescent girls and young womenDual prevention pillHIV preventionMultipurpose prevention technologiesOral contraceptivePre-exposure prophylaxis

Identifiers

PMID41251867
PMCPMC13076398

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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.