Trial reportTrials2026
Understanding trial designs and acceptability of participation in an HIV vaccine trial with concurrent randomisation to oral pre-exposure prophylaxis in East and Southern Africa: a longitudinal qualitative study.
Trial report in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04066881 (A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis), which is not on this map. Not yet cited in PubMed.
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.
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.
A Phase IIb Three-arm, Two-stage HIV Prophylactic Vaccine Trial With a Second Randomisation to Compare TAF/FTC to TDF/FTC as Pre-exposure Prophylaxis
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
introductionThis qualitative study was conducted to assess participants' understanding of the PrEPVacc trial design and factors that influenced decisions to participate in the trial. PrEPVacc was a phase IIb, three-arm, two-stage HIV prophylactic vaccine trial with a second randomisation to oral pre-exposure prophylaxis. The main objective was to assess the safety and efficacy of two HIV-1 prophylactic vaccine regimens, each compared to placebo, in preventing the acquisition of HIV.
methodsUsing a longitudinal approach, qualitative data were collected between October 2021 and September 2023. A sample of 105 participants (7% of trial participants) was purposively selected to participate in three in-depth interviews at 2, 6, and 12 months during the trial. Another 111 (92 females and 19 males) participated in 14 focus group discussions across four sites. Data were analyzed thematically.
resultsRepeated information sharing sessions facilitated by health workers helped participants understand key trial concepts and the design. Pre-exposure prophylaxis (PrEP) was widely recognised as a protective measure alongside experimental vaccines. While vaccines were preferred for convenience and minimal side effects, individual perceived HIV risk was a main motivation for adhering to PrEP. Supportive relationships with health workers and close family members encouraged engagement in the trial, including acceptance to use the products. However, misinformation and stigma in communities created barriers to participation, with some participants facing social harm.
conclusionOverall, participants demonstrated a good understanding of randomisation, double-blinding, and placebo control, facilitated by clear, repeated communication from health workers. Strengthening strategies to enhance informed consent, reduce stigma, and promote trial acceptance is crucial for successful implementation and retention. CLINICAL
trial registrationClinicalTrials.gov NCT04066881. Registered on December 15, 2020.
Indexed as
Identifiers
What OpenQuestion holds
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.