Evidence map›Paper›PMID 41214706›Full record

ArticleTrials2025

Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN).

Sylvia Kusemererwa, Bernadette Nayiga, Limakatso Lebina, Linda Gail Bekker, Andrew Philips, Loveleen Bansi- Matharu, Darshini Govindasamy, Gesine Meyer-Rath, Geofrey Kimbugwe, Eugene Ruzagira and 4 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06133686 (Implementing Oral), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

NCT06133686 phase3not yet recruitingnot on this map

Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa: a Phase 3b, Open-label, Hybrid Type 2 Implementation and Effectiveness Trial

TypeinterventionalSponsorMRC/UVRI and LSHTM Uganda Research UnitRan2024 to 2027Enrolled400ConditionsHIVArmsTenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA), Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  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

14 authors.

Sylvia KusemererwaMedical Research Council/Uganda, Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda. sylvia.kusemererwa@mrcuganda.org.ORCID http://orcid.org/0000-0002-1390-109X
Bernadette NayigaMedical Research Council/Uganda, Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Limakatso LebinaAfrica Research Health Institute, Durban, South Africa.
Linda Gail BekkerDesmond Tutu HIV Foundation, Cape Town, South Africa.
Andrew PhilipsUniversity College London, London, UK.
Loveleen Bansi- MatharuUniversity College London, London, UK.
Darshini GovindasamySouth African Medical Research Council, Cape Town, South Africa.
Gesine Meyer-RathUniversity of the Witwatersrand, Johannesburg, South Africa.
Geofrey KimbugweMedical Research Council/Uganda, Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Eugene RuzagiraMedical Research Council/Uganda, Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit , Entebbe, Uganda.
Maryam ShahmaneshAfrica Research Health Institute, Durban, South Africa.
Janet SeeleyLondon School of Hygiene and Tropical Medicine, London, UK.
Emily L WebbLondon School of Hygiene and Tropical Medicine, London, UK.
Julie FoxKing's College London, London, UK.

Funding

European Union through the Horizon/EDCTP Global Health call for vulnerable adults Project 101103140
6 · The paper itself

Abstract

backgroundMen who are mobile for work are a key population at high risk of acquiring HIV. Flexible pre-exposure prophylaxis (PrEP) options, including event-driven (ED) oral PrEP and long-acting injectable cabotegravir (CAB-LA), may offer increased access and acceptability for these men. However, limited data exist on the effectiveness and implementation of CAB-LA and ED PrEP among mobile men in Africa. Our study aims to assess the effectiveness and implementation of CAB-LA and oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (both daily and ED) through comparison of uptake, retention in care, coital coverage, and participant choice.

methodsWe will conduct a mixed0method, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomised controlled trial (RCT). The trial will be carried out in 400 HIV-negative men aged 18 years or older in South Africa and Uganda. Men will be randomised 1:1 to either Group A: oral TDF/FTC PrEP (ED or daily) or Group B: CAB-LA over 9 months. After 9 months, participants from both groups will be offered a choice of PrEP (oral TDF/FTC or CAB-LA) for a further 9 months, with the ability to change their choice as required. Various strategies to support PrEP adoption, initiation, and persistence will be implemented, monitored, and reported on using a RE-AIM (reach, effectiveness, adoption, implementation, and maintenance) implementation science framework. DISCUSSION: This study will provide critical data to inform scalable delivery models for both oral and injectable PrEP among mobile men at high risk for HIV acquisition. Findings will also highlight the potential of PrEP choice delivery and its benefits, offering evidence for governments to consider in the rollout of injectable PrEP in public health systems. Trial registration NCT06133686. Registered on 14 November 2023. PACTR202409632006463. Registered on 2 September 2024.

Indexed as

Anti-HIV AgentsEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationHIV InfectionsPre-Exposure ProphylaxisPyridonesAdministration, OralAdolescentAdultClinical Trials, Phase III as TopicDiketopiperazinesEmtricitabineHumansMaleMulticenter Studies as TopicRandomized Controlled Trials as TopicSouth AfricaAnti-HIV AgentscabotegravirDiketopiperazinesEmtricitabineEmtricitabine, Tenofovir Disoproxil Fumarate Drug CombinationPyridonesTenofovirHIVLong-acting cabotegravirMenMobile populationsPrEPSub-Saharan Africa

Identifiers

PMID41214706
PMCPMC12604281

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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.