Evidence map›Paper›PMID 33247553›Full record

Trial reportJournal of the International AIDS Society2020

Incentives conditioned on tenofovir levels to support PrEP adherence among young South African women: a randomized trial.

Connie L Celum, Katherine Gill, Jennifer F Morton, Gabrielle Stein, Laura Myers, Katherine K Thomas, Margaret McConnell, Ariane van der Straten, Jared M Baeten, Menna Duyver and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the International AIDS Society, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06446752 (A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B), which is not on this map. Cited by 62 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 2 pooled it
1.0field-weighted citation impact, top 13% of its field
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.

NCT06446752 phase3active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Phase 3 Randomized, Observer-Blind, Placebo-Controlled Study to Assess Efficacy of Meningococcal Group B (rMenB+OMV NZ (Bexsero)) in Preventing Gonococcal Infection Among South African Cis-Gender Women

TypeinterventionalSponsorUniversity of WashingtonRan2024 to 2027Enrolled1,100ConditionsGonorrhea, Gonorrhea of Pharynx, Gonorrhea of Anus, Gonorrhea of CervixArmsBexsero, Placebo
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 2 syntheses or guidelines pooled it, 76 citations in OpenAlex.

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2 more citing papers are in PubMed but not listed here.

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 at 5 institutions in 2 countries.

Connie L CelumDepartment of Global Health, University of Washington, Seattle, WA, USA.ORCID 0000-0002-8813-3419
Katherine GillThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-3372-9506
Jennifer F MortonDepartment of Global Health, University of Washington, Seattle, WA, USA.
Gabrielle SteinDepartment of Global Health, University of Washington, Seattle, WA, USA.
Laura MyersThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Katherine K ThomasDepartment of Global Health, University of Washington, Seattle, WA, USA.
Margaret McConnellChan School of Public Health, Harvard University, Boston, MA, USA.
Ariane van der StratenWomen's Global Health Imperative, RTI International, Berkeley, CA, USA.ORCID 0000-0001-8536-648X
Jared M BaetenDepartment of Global Health, University of Washington, Seattle, WA, USA.ORCID 0000-0001-8242-8438
Menna DuyverThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Eve MendelThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Keshani NaidooThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Jacqui DallimoreThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.
Lubbe WiesnerDepartment of Pharmacology, University of Cape Town, Cape Town, South Africa.
Linda-Gail BekkerThe Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa.ORCID 0000-0002-0755-4386
Desmond Tutu HIV Foundation · ZAUniversity of Washington · USHarvard University · USRTI International · USUniversity of Cape Town · ZA

Funding

Design and delivery of combination HIV prevention in young South African womenR01MH107251 · NIMH · DESMOND TUTU HIV FOUNDATION · PI BEKKER, LINDA-GAIL GAIL, CELUM, CONNIE L · 2015 to 2018
$2.0M
Gates Foundation OPP1095674NIMH NIH HHS 1RO1MH107251NIMH NIH HHS R01 MH107251
6 · The paper itself

Abstract

introductionHIV incidence remains high among African adolescent girls and young women (AGYW), who would benefit from pre-exposure prophylaxis (PrEP). Strategies to increase PrEP adherence and persistence need to be evaluated in African AGY, including incentives conditional on high adherence.

methodsThe 3Ps for Prevention Study was a 12-month prospective cohort of 200 women ages 16 to 25 initiating PrEP in South Africa from 2017 to 2018. Participants received retrospective feedback about drug levels at Months 1, 2 and 3; half was randomized to receive a 200 Rand shopping voucher ($13 US) at Months 2, 3 and 4, conditioned on high intracellular tenofovir diphosphate (TFV-DP) levels in dried blood spots (≥500 fmol/punch at Month 1, ≥700 fmol/punch at Months 2 and 3). The primary analysis was intention-to-treat, comparing the proportion with high PrEP adherence (≥700 fmol/punch) at Month 3 by randomized group, based on 100% efficacy among men who have sex with men.

resultsMedian age of the 200 women was 19 years (interquartile range [IQR] 17, 21); 86% had a primary sexual partner. At Month 3, the mean TFV-DP level was 822 fmol/punch (SD 522) in the incentive group and 689 fmol/punch (SD 546) in the control group (p = 0.11). Forty-five (56%) of 85 women in the incentive group and 35 (41%) of 85 women in the control group had TFV-DP levels ≥700 fmol/punch (RR 1.35; 95% CI 0.98, 1.86; p = 0.067), which declined to 8% and 5% in the incentive and control groups at Month 12 (no significant difference by arm). 44% refilled PrEP without gaps, 14% had a gap of ≥3 weeks in coverage subsequently restarted PrEP and 54% accepted at the final dispensing visit at Month 9. No new HIV infections were observed after PrEP initiation.

conclusionsAmong South African AGYW initiating PrEP, drug levels indicated high PrEP adherence in almost half of women at Month 3, with a non-statistically significant higher proportion with high adherence among those in the incentive group. Over half persisted with the 12-month PrEP programme although high adherence declined after Month 3. Strategies to support PrEP adherence and persistence and longer-acting PrEP formulations are needed.

Indexed as

Medication AdherenceMotivationPre-Exposure ProphylaxisAdenineAdolescentAdultAnti-HIV AgentsBlack PeopleFemaleHIV InfectionsHumansIncidenceOrganophosphatesSouth AfricaYoung AdultAdenineAnti-HIV AgentsOrganophosphatestenofovir diphosphateadherenceAfricadrug level feedbackHIV pre-exposure prophylaxisincentivesyoung women

Identifiers

PMID33247553
PMCPMC7695999
OpenAlexW3109207580

What OpenQuestion holds

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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.