HIVNCT05882916
Reaching the Last 20% (the Pamoja Kwa Afya Study)
A study testing HIV self-testing and Behavioral economic 'nudges' in people with HIV, run by Sue Napierala at 1 site in Kenya.
Trial summary
This cluster randomized controlled trial will test whether the provision of multiple oral fluid-based HIV self-test kits to women who sell sex (WSS) to secondarily distribute to their male partners who purchase sex can promote uptake of HIV service use by male partners. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HIV self-testing and Behavioral economic 'nudges'
- Type of treatment
- Pill or oral medicine, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteKenya
- Study dates
- 1 Mar 2024to 7 Aug 2026
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Age ≥18 years
- Reports exchanging sex for compensation with ≥2 men in the past month
- Engages in sex for compensation in the intervention cluster catchment area
- Willing to participate in a brief questionnaire 6 weeks after enrollment
- Plan to remain in the area of study recruitment for the next 8 weeks
Who cannot join
- Unwilling or unable to provide informed consent for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya1 site, 1 recruiting
- Recruiting
Impact Research and Development Organization (IRDO)
Kisumu
Kawango Agot, PhD, MPH, +254 736 505046, kawango@impact-rdo.org
Kawango Agot, PhD, MPH
About this study
Official title: Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya
This cluster randomized controlled trial will test whether the provision of multiple oral fluid-based HIV self-test kits to women who sell sex (WSS) to secondarily distribute to their male partners who purchase sex can promote uptake of HIV service use by male partners. The study will recruit adult women who report exchanging sex for compensation in Kisumu and Siaya counties in Western Kenya. In clusters randomized to the intervention, WSS will be given multiple HIV self-tests and counseled to distribute them to men who purchase sex (MPS). Self-test kits will contain instructions for use and tailored information on clinic location and hours within the cluster, and pilot-tested messaging on the benefits of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). In control clusters, standard of care HIV services will continue to be available. To objectively assess impacts of the intervention on post-HIVST linkage outcomes, the investigators will monitor use of HIV services by men at HIV clinics in both study arms on a monthly basis. Our goal will be to determine whether confirmatory testing (primary outcome), case diagnoses, ART initiation, and PrEP initiation by men in intervention clusters are higher than in control clusters. Mixed methods research will be utilized to conduct a process evaluation to assess mechanisms that may have impacted intervention effectiveness, pathways for linkage among MPS, and support for men's linkage to HIV services under a secondary distribution model. Cost-effectiveness analyses will also be undertaken.
Read the detailed description
Limited use of HIV services by those at highest risk is one of the primary reasons for continued HIV transmission in sub-Saharan Africa. Identifying and engaging these individuals-particularly the 20% of people living with HIV who are unaware of their status-is a major challenge that is not being met by existing service delivery approaches. Men who purchase sex (MPS) are of particularly high priority because they are twice as likely to be HIV-infected as other men and are inherently challenging to identify and reach with HIV services. The proposed project will take place in the region of Kenya with the highest HIV prevalence and seeks to promote engagement in HIV testing, prevention, and care by MPS. Preliminary data demonstrate that "secondary distribution" of HIV self-tests by women who sell sex (WSS) to their sexual partners is acceptable, feasible, and safe and leads to high male partner testing. However, the use of post-self-test services has seldom been promoted or measured in a secondary distribution model. Our interdisciplinary and experienced team of Investigators will address this key gap.
This project will use a stepped wedge trial design to test an innovative, well-targeted HIV self-test secondary distribution intervention to promote uptake of HIV services by MPS. Clusters served by Ministry of Health-supported HIV clinics will be randomized to the start time to receive the secondary distribution intervention. The investigators will recruit WSS from key population clinics and transactional sex "hot spots." WSS will be provided with oral fluid-based HIV self-tests and encouraged to distribute them to their male transactional sex partners. Self-test kits will include salient information for men on clinic location and hours within their cluster, and pilot-tested messaging on the importance of early ART initiation, and the availability and benefits of PrEP. In Aim 1, the investigators will evaluate programmatic data from HIV clinics in study clusters to objectively determine the intervention's impact on uptake of confirmatory testing, HIV case diagnoses, and ART initiation and PrEP initiation by men. In Aim 2, the investigators will conduct a process evaluation to characterize factors influencing intervention effectiveness. The investigators will assess secondary distribution patterns and characterize the MPS population receiving self-tests through quantitative program data and a follow-up questionnaire among enrolled WSS. The investigators will use qualitative data obtained through in-depth interviews with MPS, WSS and clinic staff to explore pathways and contextual factors influencing whether men accessed post-test services. In Aim 3, the investigators will compute the incremental cost-effectiveness of our intervention to inform decisions about broader implementation. This project has the potential to break new ground on ways to engage high-risk and hard-to-reach populations in HIV services. If effective, our approach could be readily adapted to other settings and help advance global goals for HIV elimination.
- Conditions
- HIV
- Being tested
- HIV self-testing, Behavioral economic 'nudges'
- Keywords
- Self-testing, Secondary distribution, Men who purchase sex, Women who sell sex, HIV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV self-testingDevice
Oral fluid-based HIV self-test kits for secondary distribution
Behavioral economic 'nudges'Behavioural
Salient information for men included with the self-test kit on clinic location and hours within their cluster, and pilot-tested messaging on the importance of early ART initiation, and the availability and benefits of PrEP
| Study group | Role | What they receive |
|---|---|---|
| HIV self-test secondary distribution | Experimental | The investigators will provide women who sell sex enrolled in the study with multiple World Health Organization (WHO) and Kenya-approved oral fluid-based HIV self-test kits. Participants will be counseled to secondarily distribute self-tests to their male transactional sex partners. Self-test kits will contain instructions for use and tailored information on clinic locations and hours within the cluster, the benefits of early ART use, and the availability and benefits of PrEP. Receives: Device: HIV self-testing; Behavioral: Behavioral economic 'nudges' |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV testing
The count of adult men from each cluster who completed an HIV test at the clinic within the intervention versus control period.
Measured: 3 months
Secondary outcomes (2)
HIV case diagnoses
The test positivity rate at the clinic (proportion of men who obtain an HIV-positive result) within the intervention versus control period.
Measured: 3 months
ART and PrEP initiation
The count of adult men from each cluster who initiated ART or PrEP at the clinic within the intervention versus control period.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start1 Mar 2024
- Primary completion29 May 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- randomized stepped wedge trial
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sue Napierala
- Sponsor type
- University, hospital or other
- Collaborators
- Impact Research & Development Organization, University of Pennsylvania, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor-investigator, Sue Napierala, RTI International
- Investigators
- Sue Napierala, PhD, MPH, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05882916
- Sponsor's protocol ID
- 0218622
- Status last verified
- Mar 2025
- First submitted
- 18 May 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV. 2016 Jun;3(6):e266-74. doi: 10.1016/S2352-3018(16)00041-2. Epub 2016 Apr 8.
PubMed 27240789Thirumurthy H, Bair EF, Ochwal P, Marcus N, Putt M, Maman S, Napierala S, Agot K. The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial. Lancet HIV. 2021 Dec;8(12):e736-e746. doi: 10.1016/S2352-3018(21)00248-4.
PubMed 34856179Napierala S, Bair EF, Marcus N, Ochwal P, Maman S, Agot K, Thirumurthy H. Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial. J Int AIDS Soc. 2020 Jun;23 Suppl 2(Suppl 2):e25515. doi: 10.1002/jia2.25515.
PubMed 32589354Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med. 2016 Nov 8;13(11):e1002166. doi: 10.1371/journal.pmed.1002166. eCollection 2016 Nov.
PubMed 27824882
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reaching the Last 20%: a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya
- ClinicalTrials.gov ID
- NCT05882916
- Acronym / sponsor ID
- 0218622
- Conditions
- HIV
- Keywords
- Self-testing, Secondary distribution, Men who purchase sex, Women who sell sex, HIV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sue NapieralaUniversity, hospital or other
- Collaborators
- Impact Research & Development Organization, University of Pennsylvania, University of North Carolina, Chapel Hill
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 29 May 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 31 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cluster randomized controlled trial will test whether the provision of multiple oral fluid-based HIV self-test kits to women who sell sex (WSS) to secondarily distribute to their male partners who purchase sex can promote uptake of HIV service use by male partners. The study will recruit adult women who report exchanging sex for compensation in Kisumu and Siaya counties in Western Kenya. In clusters randomized to the intervention, WSS will be given multiple HIV self-tests and counseled to distribute them to men who purchase sex (MPS). Self-test kits will contain instructions for use and tailored information on clinic location and hours within the cluster, and pilot-tested messaging on the benefits of antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP). In control clusters, standard of care HIV services will continue to be available. To objectively assess impacts of the intervention on post-HIVST linkage outcomes, the investigators will monitor use of HIV services by men at HIV clinics in both study arms on a monthly basis. Our goal will be to determine whether confirmatory testing (primary outcome), case diagnoses, ART initiation, and PrEP initiation by men in intervention clusters are higher than in control clusters. Mixed methods research will be utilized to conduct a process evaluation to assess mechanisms that may have impacted intervention effectiveness, pathways for linkage among MPS, and support for men's linkage to HIV services under a secondary distribution model. Cost-effectiveness analyses will also be undertaken.
Detailed description
Limited use of HIV services by those at highest risk is one of the primary reasons for continued HIV transmission in sub-Saharan Africa. Identifying and engaging these individuals-particularly the 20% of people living with HIV who are unaware of their status-is a major challenge that is not being met by existing service delivery approaches. Men who purchase sex (MPS) are of particularly high priority because they are twice as likely to be HIV-infected as other men and are inherently challenging to identify and reach with HIV services. The proposed project will take place in the region of Kenya with the highest HIV prevalence and seeks to promote engagement in HIV testing, prevention, and care by MPS. Preliminary data demonstrate that "secondary distribution" of HIV self-tests by women who sell sex (WSS) to their sexual partners is acceptable, feasible, and safe and leads to high male partner testing. However, the use of post-self-test services has seldom been promoted or measured in a secondary distribution model. Our interdisciplinary and experienced team of Investigators will address this key gap.
This project will use a stepped wedge trial design to test an innovative, well-targeted HIV self-test secondary distribution intervention to promote uptake of HIV services by MPS. Clusters served by Ministry of Health-supported HIV clinics will be randomized to the start time to receive the secondary distribution intervention. The investigators will recruit WSS from key population clinics and transactional sex "hot spots." WSS will be provided with oral fluid-based HIV self-tests and encouraged to distribute them to their male transactional sex partners. Self-test kits will include salient information for men on clinic location and hours within their cluster, and pilot-tested messaging on the importance of early ART initiation, and the availability and benefits of PrEP. In Aim 1, the investigators will evaluate programmatic data from HIV clinics in study clusters to objectively determine the intervention's impact on uptake of confirmatory testing, HIV case diagnoses, and ART initiation and PrEP initiation by men. In Aim 2, the investigators will conduct a process evaluation to characterize factors influencing intervention effectiveness. The investigators will assess secondary distribution patterns and characterize the MPS population receiving self-tests through quantitative program data and a follow-up questionnaire among enrolled WSS. The investigators will use qualitative data obtained through in-depth interviews with MPS, WSS and clinic staff to explore pathways and contextual factors influencing whether men accessed post-test services. In Aim 3, the investigators will compute the incremental cost-effectiveness of our intervention to inform decisions about broader implementation. This project has the potential to break new ground on ways to engage high-risk and hard-to-reach populations in HIV services. If effective, our approach could be readily adapted to other settings and help advance global goals for HIV elimination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- randomized stepped wedge trial
| Arm | Type | Receives |
|---|---|---|
| HIV self-test secondary distribution | Experimental | Device: HIV self-testing, Behavioral: Behavioral economic 'nudges'The investigators will provide women who sell sex enrolled in the study with multiple World Health Organization (WHO) and Kenya-approved oral fluid-based HIV self-test kits. Participants will be counseled to secondarily distribute self-tests to their male transactional sex partners. Self-test kits will contain instructions for use and tailored information on clinic locations and hours within the cluster, the benefits of early ART use, and the availability and benefits of PrEP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- Age ≥18 years
- Reports exchanging sex for compensation with ≥2 men in the past month
- Engages in sex for compensation in the intervention cluster catchment area
- Willing to participate in a brief questionnaire 6 weeks after enrollment
Key exclusion criteria (1 listed)
- Unwilling or unable to provide informed consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIV self-testingOral fluid-based HIV self-test kits for secondary distribution | Device | HIV self-test secondary distribution |
| Behavioral economic 'nudges'Salient information for men included with the self-test kit on clinic location and hours within their cluster, and pilot-tested messaging on the importance of early ART initiation, and the availability and benefits of PrEP | Behavioural | HIV self-test secondary distribution |
Primary outcome
HIV testing
Time frame: 3 months
The count of adult men from each cluster who completed an HIV test at the clinic within the intervention versus control period.
2 secondary outcomes
HIV case diagnoses
Time frame: 3 months
ART and PrEP initiation
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Background: PubMed 27240789Thirumurthy H, Masters SH, Mavedzenge SN, Maman S, Omanga E, Agot K. Promoting male partner HIV testing and safer sexual decision making through secondary distribution of self-tests by HIV-negative female sex workers and women receiving antenatal and post-partum care in Kenya: a cohort study. Lancet HIV. 2016 Jun;3(6):e266-74. doi: 10.1016/S2352-3018(16)00041-2. Epub 2016 Apr 8.
- Background: PubMed 34856179Thirumurthy H, Bair EF, Ochwal P, Marcus N, Putt M, Maman S, Napierala S, Agot K. The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial. Lancet HIV. 2021 Dec;8(12):e736-e746. doi: 10.1016/S2352-3018(21)00248-4.
- Background: PubMed 32589354Napierala S, Bair EF, Marcus N, Ochwal P, Maman S, Agot K, Thirumurthy H. Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial. J Int AIDS Soc. 2020 Jun;23 Suppl 2(Suppl 2):e25515. doi: 10.1002/jia2.25515.
- Background: PubMed 27824882Masters SH, Agot K, Obonyo B, Napierala Mavedzenge S, Maman S, Thirumurthy H. Promoting Partner Testing and Couples Testing through Secondary Distribution of HIV Self-Tests: A Randomized Clinical Trial. PLoS Med. 2016 Nov 8;13(11):e1002166. doi: 10.1371/journal.pmed.1002166. eCollection 2016 Nov.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue Napierala, PhD, MPH principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIV self-testing and Behavioral economic 'nudges' in people with HIV, run by Sue Napierala at 1 site in Kenya.
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 1 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: looking for participants now, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Sue Napierala, PhD, MPH (5104188198, snapierala@rti.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV testing (time frame: 3 months). 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 NCT05882916, which also lists 4 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 18 Mar 2025.