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HIVPhase 3MOBILEMENNCT06133686

Implementing Oral (Event-driven and Daily) and Long-acting Pre-Exposure Prophylaxis in Mobile Men in Sub-Saharan Africa

A Phase 3 study testing Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA) and Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) in people with HIV, run by MRC/UVRI and LSHTM Uganda Research Unit.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). Read more about this study

Who is it for?
Ages 18 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA) and Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
1 Apr 2024to 1 Apr 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Able and willing to provide informed consent
  • Aged 18 years and above on the day of screening
  • Willing to have a HIV test and receive the test results
  • Male at birth
  • In the past 6-months has travelled for work or to find work and spent at least one night away from home for work related purposes.
  • Available for follow up for the duration of the study

Who cannot join

  • Known HIV infection
  • Confirmed HIV-positive test result, indeterminate HIV test result, and/or signs and symptoms of an acute HIV infection
  • Body weight less than 35Kg at baseline
  • Allergy to any of the study products
  • Medical, social or other condition that, in the opinion of the site investigator, would interfere with the conduct of the study or safety of the participant (e.g., provided by self-report, or found upon medical history and examination or in available medical records)
  • Use of contraindicated medications: Medication for tuberculosis (Rifampin, rifapentine) or anticonvulsants (Carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
  • Other reasons at the discretion of site investigator for unsuitability for study inclusion

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Berna Nayiga, MSc contact

0417704000

Berna.Kalanzi@mrcuganda.org

Sylvia Kusemererwa, MPH contact

0417704000

sylvia.kusemererwa@mrcuganda.org

About this study

Official title: 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

Title: Implementing oral (event-driven and daily) and long-acting Pre-exposure prophylaxis (PrEP) in mobile men in Sub-Saharan Africa

Design: A mixed method, multi-setting, multi-country, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried out in 400 HIV negative men aged 18+ years in South Africa and Uganda. Men will be randomized 1:1 to either Group A: oral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) PrEP (event-driven or daily) or Group B: Long-acting injectable cabotegravir (CAB-LA) over 9-months. After 9-months participants from both groups will be offered choice of PrEP (oral TDF-FTC or CAB-LA) for a further 9-months, with the ability to change 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.

Treatment: CAB-LA or oral TDF-FTC Duration: 18 months

Read the detailed description

BACKGROUND HIV prevention pre-exposure prophylaxis (PrEP) has not been evaluated in men who mainly have sex with women and who may be at high risk of HIV acquisition due to high HIV prevalence in partners or particularly risky behaviours. Research to fill these data gaps is required to facilitate their inclusion in PrEP guidelines. Furthermore, with increasing PrEP options, recommendations to users and providers in high-burden / resource constrained settings is a key focus of the Sustainable Development Goal target to end AIDS by 2030. To date, HIV prevention research has largely focussed on adolescent girls and young women (AGYW) in low and middle income countries and men who have sex with men (MSM) in high income countries. Research on the user experience and choice of oral PrEP or CAB-LA PrEP amongst vulnerable heterosexual men is required.

Men consistently fare worse than women in levels of HIV testing and ART initiation with significant challenges in sub-Saharan Africa (SSA) for engagement and persistence in HIV treatment programmes well described. Despite this, heterosexual men represent the largest unaddressed gap in HIV services in SSA. Indeed, the failure of Treatment As Prevention trials (TASP) to show effect was in the main due to the failure to test and treat young men. Men who are mobile for work or through looking for work, are viewed by the WHO as a key population at high risk for HIV. As Africa's large youth bulge moves into young adulthood, the search for work and consequent mobile lifestyles will further increase.

In order to improve uptake, persistence, and effective use of all forms of PrEP, there is a need for simplified and differentiated delivery of PrEP that is person- and community-centred specifically for men. Effective use requires that all sex acts are covered by an effective prevention intervention such as PrEP. Given the importance of flexibility due to travel in this group, our hypothesis is that both oral PrEP (in particular, event-driven) and CAB-LA PrEP will be highly acceptable to men in two high-burden, resource limited, African countries, with high levels of effective use including persistence and coital coverage.

This is the first multi-country PrEP study for implementing both event-driven oral PrEP and Long-acting injectable cabotegravir (CAB-LA) in men in SSA (South Africa and Uganda). The programme will provide the evidence and cost-effectiveness analysis which is critical to decision making by African governments and donors on how to prioritise prevention resources and inform guidelines.

STUDY OBJECTIVES Effective use is defined as PrEP uptake and persistence, retention in care, and HIV exposure coverage with adequate drug tissue levels.

Overall Objective To assess effectiveness and implementation of CAB-LA and oral TDF-FTC (both daily and event driven) through comparison of uptake, retention in care, coital coverage, and participant choice

Primary Objective

  1. Primary user effectiveness objective: To compare short term (9 months) and longer term (18 months) PrEP persistence patterns across different PrEP modalities (oral and injectable) amongst men who are mobile for work in South Africa and Uganda.
  2. Primary implementation objective: To compare adoption (uptake and choice) across the different PrEP modalities (oral and injectable) amongst men who are mobile for work in South Africa and Uganda.

Adoption is defined as 1) uptake: do people accept and use the intervention they're randomised to, and 2) choice: based on the post-randomised period, i.e., months 9-18, what PrEP do they choose)

Secondary clinical objectives

  1. To compare the effective coital coverage of oral daily/on-demand oral TDF-FTC versus CAB-LA
  2. To describe the safety, tolerability and acceptance of all methods, as determined by self-reported adverse side effects, AEs and reasons for PrEP pause or discontinuation.

Secondary implementation objectives:

  1. To understand the Reach of PrEP for mobile men and understand the barriers to and facilitators of uptake amongst those at risk who do and do not accept oral or LA PrEP.
  2. To describe adoption:
  3. To identify characteristics of men who adopt oral PrEP versus CAB-LA
  4. To describe patterns of use of daily, on-demand, and long-acting PrEP amongst different groups of mobile men.
  5. To understand the implementation of on-demand and long-acting PrEP for mobile men amongst service providers to inform scale-up.
  6. To understand the feasibility and fidelity of delivering on-demand and long-acting PrEP in different settings.
  7. To describe how on-demand and long-acting PrEP are delivered in practice.
  8. To describe the service-level needs to implement on-demand and long-acting PrEP.
  9. To evaluate acceptabiltiy and implementation of antibody based monitoring HIV status for CAB-LA.
  10. To assess the total and average cost of oral PrEP and CAB-LA in South Africa and Uganda under study conditions from the provider perspective (Maintenance).

Exploratory objectives

  1. To describe HIV incidence across the two PrEP modality arms
  2. To describe any evidence of HIV drug resistance mutations in participants who acquire HIV infection whilst using PrEP across the two PrEP modality arms.
  3. To describe persistence in care of those diagnosed HIV infected at screening.
  4. To describe body mass index (BMI) and blood pressure across both arms.

STUDY DESIGN We will use a hybrid effectiveness implementation type 2 trial to evaluate the initial implementation (scale-up) phase of CAB-LA as a PrEP option in men who are mobile for work in South Africa and Uganda with a high burden of HIV. This is a Phase 3b, open label, hybrid type 2 study with co-primary aims of effective use and implementation.

This is a mixed method, multi-setting, multi-country randomized controlled trial (RCT), carried out in South Africa and Uganda to compare persistence in care for oral PrEP and CAB-LA in mobile men, which will inform PrEP implementation in men. Mobile men aged 18+ years, will be recruited from outreach settings in South Africa and Uganda. Those testing HIV negative (target sample size, n=400) will be randomized into 2 groups: Group A will receive oral TDF-FTC PrEP (using either event-driven or daily) and Group B will receive CAB-LA over 9-months. After 9- months participants from both groups will be offered choice of PrEP for a further 9-months, with the ability to change choice as required. Switch PrEP options will be monitored. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP.

Implementation Framework: The project utilises the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance) to evaluate MOBILE MEN's PrEP delivery preferences and patterns of use.

Participants will be supported in taking PrEP and the social science and implementation science data collection will feedback findings in real time, on the ways to facilitate men to maximise their adherence to PrEP.

Healthcare providers will be trained to deliver oral (daily and event driven) and injectable PrEP, develop services which are mobile men friendly- non-judgemental, timing and location appropriate for men.

Data will be collected in Uganda and South Africa.

Recruitment settings:

A decentralized model of care for recruitment and persistence in ongoing study will be developed whereby study visits will be conducted through mobile and outreach clinics. Demand creation for PrEP will take place through a community engagement campaign and peer outreach activities prior to the study starting, whereby men in the communities are exposed to PrEP educational materials and encouraged to visit community and public health sites to access sexual health services, including PrEP. Potential participants will be provided with educational information about each of the PrEP products through both the enrolment visit and as part of a community-wide demand creation campaign which precedes the study.

Conditions
HIV
Being tested
Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA), Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)
Keywords
Mobile Men, HIV, Pre-exposure prophylaxis, Truvada, Cabotegravir

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA)Drug

    Group A will receive oral TDF-FTC PrEP (using either event-driven or daily) for 9-months. After 9-months, participants will be offered choice of PrEP (either TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP

  • Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)Drug

    Group B will receive CAB-LA for 9-months. After 9-months participants will be offered choice of PrEP (either TDF-FTC or CAB-LA) for a further 9-months, with the ability to change choice as required. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP.

Study groups in NCT06133686
Study groupRoleWhat they receive
Group AOtherOral Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) followed by choice of TDF-FTC or CAB-LA
Receives: Drug: Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA)
Group BOtherLong-acting injectable cabotegravir (CAB-LA) followed by choice of TDF-FTC or CAB-LA
Receives: Drug: Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary user effectiveness outcome will be the persistent use of PrEP in the randomised period and throughout the full follow-up period.

    Persistence will be a binary outcome capturing whether a participant has used PrEP persistently or not. For participants receiving CAB-LA, this will be based on whether they received all injections as per schedule or not. For participants receiving TDF-FTC, this will be based on whether they have attended scheduled visits, had TDF-FTC dispensed, and have detectable TFV-DP levels in dried blood spots.

    Measured: 18 months

  2. The primary implementation outcome will be PrEP adoption

    PrEP adoption was assessed as uptake of PrEP in months 0-9. This is a binary variable that will capture whether or not a participant was offered and took up the offer of PrEP during the 9-month randomized period.

    Measured: 18 months

  3. The primary implementation outcome will be PrEP adoption

    PrEP adoption was assessed as the choice preference of PrEP in months 9-18. This is a categorical variable that will measure the proportions that choose and uptake each modality (daily or event-driven TDF-FTC or CAB-LA) captured at the start and the end of the subsequent 9-month choice period

    Measured: 18 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2023
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a Phase 3b, open label, hybrid type 2 study with co-primary aims of effective use and implementation. This is a mixed method, multi-setting, multi-country randomized controlled trial, carried out in South Africa and Uganda to compare persistence in care for oral PrEP and CAB-LA in mobile men, which will inform PrEP implementation in men. Mobile men aged 18+ years, will be recruited from outreach settings in in South Africa and Uganda. Those testing HIV negative (target sample size, n=400) will be randomized into 2 groups: Group A will receive oral TDF-FTC PrEP (using either event-driven or daily) and Group B will receive CAB-LA over 9-months. After 9- months participants from both groups will be offered choice of PrEP for a further 9-months, with the ability to change choice as required. Switch PrEP options will be monitored. Those receiving oral PrEP will be able to choose between event-driven and daily PrEP with the emphasis on coital coverage by PrEP.
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06133686
Sponsor's protocol ID
RGDER231010
Acronym
MOBILEMEN
Status last verified
Nov 2023
First submitted
19 Oct 2023
Last updated
15 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The team is committed to open access data. The results of the study and anonymized data sets will be published in open access peer-reviewed journals and data repositories.

Publications

  • Zhang J, Li C, Xu J, Hu Z, Rutstein SE, Tucker JD, Ong JJ, Jiang Y, Geng W, Wright ST, Cohen MS, Shang H, Tang W. Discontinuation, suboptimal adherence, and reinitiation of oral HIV pre-exposure prophylaxis: a global systematic review and meta-analysis. Lancet HIV. 2022 Apr;9(4):e254-e268. doi: 10.1016/S2352-3018(22)00030-3.

    PubMed 35364026

  • Giguere K, Eaton JW, Marsh K, Johnson LF, Johnson CC, Ehui E, Jahn A, Wanyeki I, Mbofana F, Bakiono F, Mahy M, Maheu-Giroux M. Trends in knowledge of HIV status and efficiency of HIV testing services in sub-Saharan Africa, 2000-20: a modelling study using survey and HIV testing programme data. Lancet HIV. 2021 May;8(5):e284-e293. doi: 10.1016/S2352-3018(20)30315-5. Epub 2021 Mar 2.

    PubMed 33667411

  • Iwuji CC, Orne-Gliemann J, Larmarange J, Balestre E, Thiebaut R, Tanser F, Okesola N, Makowa T, Dreyer J, Herbst K, McGrath N, Barnighausen T, Boyer S, De Oliveira T, Rekacewicz C, Bazin B, Newell ML, Pillay D, Dabis F; ANRS 12249 TasP Study Group. Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial. Lancet HIV. 2018 Mar;5(3):e116-e125. doi: 10.1016/S2352-3018(17)30205-9. Epub 2017 Nov 30.

    PubMed 29199100

  • The Global Men and HIV Technical Working Group (MENHT). HIV gap in men. HIV gap in men: the Global Men and HIV Technical Working Group (MENHT) Webinar Series - Episode #4 (who.int) 2021.

  • Delany-Moretlwe S, Hughes JP, Bock P, Ouma SG, Hunidzarira P, Kalonji D, Kayange N, Makhema J, Mandima P, Mathew C, Spooner E, Mpendo J, Mukwekwerere P, Mgodi N, Ntege PN, Nair G, Nakabiito C, Nuwagaba-Biribonwoha H, Panchia R, Singh N, Siziba B, Farrior J, Rose S, Anderson PL, Eshleman SH, Marzinke MA, Hendrix CW, Beigel-Orme S, Hosek S, Tolley E, Sista N, Adeyeye A, Rooney JF, Rinehart A, Spreen WR, Smith K, Hanscom B, Cohen MS, Hosseinipour MC; HPTN 084 study group. Cabotegravir for the prevention of HIV-1 in women: results from HPTN 084, a phase 3, randomised clinical trial. Lancet. 2022 May 7;399(10337):1779-1789. doi: 10.1016/S0140-6736(22)00538-4. Epub 2022 Apr 1.

    PubMed 35378077

  • Abstracts from the 2022 Conference on Retroviruses and Opportunistic Infections. Top Antivir Med. 2022 Mar;30(1s):3-382. No abstract available.

    PubMed 35298110

  • World Health Organization : Differentiated and simplified pre-exposure prophylaxis for HIV prevention: update to WHO implementation guidance. Technical Brief. Geneva: World Health Organization; 2022. Licence: CC BY.

  • Guidelines on Long-Acting Injectable Cabotegravir for HIV Prevention [Internet]. Geneva: World Health Organization; 2022. Available from http://www.ncbi.nlm.nih.gov/books/NBK586584/

    PubMed 36417549

  • Philbin MM, Parish C, Kinnard EN, Reed SE, Kerrigan D, Alcaide ML, Cohen MH, Sosanya O, Sheth AN, Adimora AA, Cocohoba J, Goparaju L, Golub ET, Fischl M, Metsch LR. Interest in Long-Acting Injectable Pre-exposure Prophylaxis (LAI PrEP) Among Women in the Women's Interagency HIV Study (WIHS): A Qualitative Study Across Six Cities in the United States. AIDS Behav. 2021 Mar;25(3):667-678. doi: 10.1007/s10461-020-03023-9.

    PubMed 32910351

  • Sued O, Nardi N, Spadaccini L. Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review. Curr Opin HIV AIDS. 2022 May 1;17(3):145-161. doi: 10.1097/COH.0000000000000734. Epub 2022 Apr 18.

    PubMed 35439789

  • Johnson L, Dorrington R. Thembisa version 4.6: National and Provincial Model Outputs. Thembisa. 2023. Available from: https://www.thembisa.org/content/downloadPage/ProvOutput4_6 (Accessed July 4, 2023).

  • Johnson LF, Dorrington RE, Moolla H. Progress towards the 2020 targets for HIV diagnosis and antiretroviral treatment in South Africa. South Afr J HIV Med. 2017 Jul 27;18(1):694. doi: 10.4102/sajhivmed.v18i1.694. eCollection 2017.

    PubMed 29568630

  • Simbayi L, Zuma K, Zungu N, Moyo S, Marinda E, Jooste S, Mabaso M, Ramlangan S, North A, van Zyl J, Mohlabane N, Dietrich C, Naidoo I, SABSSM V Team. South African national HIV prevalence, incidence, behaviour and communication survey, 2017: towards achieving the UNAIDS 90-90-90 targets [Internet]. 2019 [cited 2021 Apr 4]. Available from: http://repository.hsrc.ac.za/handle/20.500.11910/15052

  • Nglazi MD, van Schaik N, Kranzer K, Lawn SD, Wood R, Bekker LG. An incentivized HIV counseling and testing program targeting hard-to-reach unemployed men in Cape Town, South Africa. J Acquir Immune Defic Syndr. 2012 Mar 1;59(3):e28-34. doi: 10.1097/QAI.0b013e31824445f0.

    PubMed 22173039

  • Bazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, Biello KB, Roth AM, Strathdee SA, Pines HA. Long-Acting Injectable Human Immunodeficiency Virus Pre-Exposure Prophylaxis Preferred Over Other Modalities Among People Who Inject Drugs: Findings from a Qualitative Study in California. AIDS Patient Care STDS. 2022 Jul;36(7):254-262. doi: 10.1089/apc.2022.0068. Epub 2022 Jun 21.

    PubMed 35727647

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC), cabotegravir (CAB-LA) and Cabotegravir (CAB-LA), Tenofovir disoproxil fumarate/emtricitabine (TDF-FTC) in people with HIV, run by MRC/UVRI and LSHTM Uganda Research Unit.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Berna Nayiga, MSc (0417704000, Berna.Kalanzi@mrcuganda.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary user effectiveness outcome will be the persistent use of PrEP in the randomised period and throughout the full follow-up period. (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06133686, which also lists 44 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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