HIV Prevention and CareNCT06238323
Lafiya HIV Self-testing Study Protocol
A study testing LAFIYA in people with HIV Prevention and Care, run by University of Rochester at 1 site in Ghana.
Trial summary
The study aims to address low testing and related issues such as stigma, low-risk perception, and concerns about confidentiality affecting testing. To overcome these challenges, the study proposes to adapt the Many Men Many Voices (3MV) into a modified version called LAFIYA to tackle intersectional stigma and improve… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention and Care
- What is being tested?
- LAFIYA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGhana
- Study dates
- 1 Feb 2025to 30 Mar 2027
- 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 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- YSMM: To be eligible to participate in the interview, the person must be between 18 to 25 years old, have no experience using unassisted HIVST kits, do not know their HIV status or tested negative, currently identifies as cis-gender man, and have had sex with another man within six months before engaging with the recruitment team and must reside within a slum community in the Greater Accra Metropolitan area.
- Providers: To be eligible to participate in the interview, the person must have experience providing sexual health services such as HIV testing, counseling, and linkage to prevention and care services for at least one year. Must reside within the Greater Accra Metropolitan area and have worked with YSMM on HIV prevention and care.
Who cannot join
- YSMM: Those who fall under 18 years or above 25 years will be excluded from the study. YSMM who have experience with unassisted HIVST kits, know their HIV status, or tested positive for HIV will be excluded from the study. YSMM who do not identify as cis-gender man and have not had sex with another man within six months before engaging with the recruitment team will be excluded from the study. YSMM who do not reside within a slum community in the Greater Accra Metropolitan area will be excluded from the study.
- Providers: Persons who do not have experience providing services such as HIV testing, counseling, and linkage to prevention and care services for at least one year will be excluded from the study. Providers not residing within the Greater Accra Metropolitan area and have not worked with YSMM on HIV prevention and care will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adaptation and Feasibility of Many Men Many Voices (3MV), an HIV Prevention Intervention to Reduce Intersectional Stigma and Increase HIVST Among YSMM Residing in Ghanaian Slums - A Clustered Pre-post Pilot Trial Protocol
The study aims to address low testing and related issues such as stigma, low-risk perception, and concerns about confidentiality affecting testing. To overcome these challenges, the study proposes to adapt the Many Men Many Voices (3MV) into a modified version called LAFIYA to tackle intersectional stigma and improve HIVST among young sexual minority men in Ghana.
- Conditions
- HIV Prevention and Care
- Being tested
- LAFIYA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAFIYABehavioural
LAFIYA will be a modified version of the Many Men Many Voices (3MV) targeted at addressing reducing stigma and increasing HIV self-testing uptake among young sexual minority men. LAFIYA will be developed into a comprehensive intervention manual for a large-scale trial using the ADAPTT-IT framework.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Experimental | Participants will be young sexual minority men (YSMM) and providers from healthcare institutions working with YSMM. Receives: Behavioral: LAFIYA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in percentage of participants that reported the intervention as acceptable
Participants will be provided with a survey that inquires if HIVST meets their approval, meets their needs, and if they welcome the use of HIVST. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.
Measured: Baseline to 3 months
Change in percentage of participants that reported the intervention as appropriate
Participants will be provided with a survey that inquires if HIVST seems reasonable, if HIVST seems like a good match, and if HIVST seems applicable. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.
Measured: Baseline to 3 months
Change in percentage of participants that reported the intervention as feasible.
Participants will be provided with a survey that inquires if HIVST seems easy to use, if HIVST seems challenging, and if HIVST seems practical. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.
Measured: Baseline to 3 months
Secondary outcomes (10)
Change in the number of HIV tests
We are going to collect the total number of HIV tests performed by all participants and report the mean change in number.
Measured: Baseline to 3 months
Mean change in the Basic Needs Satisfaction Scale.
The Basic Needs Satisfaction scale is a 9 question scale that asks participants general questions about experiences of feeling free within their community while identifying as YSMM. The outcome measure will analyze changes in average scores over time. The Basic Needs Satisfaction Scale is scored on a scale ranging from 1 to 10, where 1 represents the lowest possible level of basic needs satisfaction, and 10 represents the highest
Measured: Baseline to 3 months
Percentage of participants to report resilience/bouncing back after hard times.
Participants will be provided with a 6 question survey that inquires into a percentage change in their level of resilience. Each question inquires into their ability to bounce back or cope with challenges, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Percentage of participants that reported enacted stigma.
Participants will be provided with a 10 question survey that inquires into the rate at which they experienced unfair treatment by others. Each question will inquire into experiences of unfair treatment, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated for an overall percent score.
Measured: Baseline to 3 months
Percentage of participants that reported vicarious stigma.
Participants will be provided with a 10 question survey that inquires into the percentage rate at which they have heard stories about other YSMM stigma experiences. Each question inquires whether they have heard stories of other YSMM experiencing stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Percentage of participants that reported perceived stigma.
Participants will be provided with a 10 question survey that inquires into the level of agreement or disagreement on perceived stigma. Each question inquires whether they agree or disagree with perceived stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Percentage in participants that reported internalized stigma.
Participants will be provided with a 10 question survey that inquires into the percentage change in internalized stigma. Each question inquires into their experience of internalized stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Percentage of participants that reported stigma for involving in same sex relations.
Participants will be provided with a 10 question survey that inquires into the frequency at which they encounter stigma from engaging in same-sex relations. Each question inquires into their experiences of stigma from engaging in same-sex relationships, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Percentage of participants that reported stigma from being gender non-conforming.
Participants will be provided with a 10 question survey that inquires into the frequency at which they encounter stigma due to their feminine mannerisms. Each question inquires into their experiences of stigma from being gender non-conforming, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Healthcare climate
Participants will be provided with a 6 question survey that inquires into the frequency at which they encounter negative health provider attitudes. Each question inquires into their experiences when dealing with health providers, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Feb 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Prevention and CareStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana, George Washington University, Yale University, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Gamji Rabiu Abu-Ba'are, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238323
- Sponsor's protocol ID
- STUDY00008385
- Other IDs
- R01TW012671
- Status last verified
- Jun 2026
- First submitted
- 25 Jan 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Feasibility of Many Men Many Voices (3MV), an HIV Prevention Intervention to Reduce Intersectional Stigma and Increase HIVST Among YSMM Residing in Ghanaian Slums - A Clustered Pre-post Pilot Trial Protocol
- ClinicalTrials.gov ID
- NCT06238323
- Acronym / sponsor ID
- STUDY00008385
- Conditions
- HIV Prevention and Care
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- University of Ghana, George Washington University, Yale University, Fogarty International Center of the National Institute of Health
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 2 Feb 2024 (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.
The study aims to address low testing and related issues such as stigma, low-risk perception, and concerns about confidentiality affecting testing. To overcome these challenges, the study proposes to adapt the Many Men Many Voices (3MV) into a modified version called LAFIYA to tackle intersectional stigma and improve HIVST among young sexual minority men in Ghana.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | Experimental | Behavioral: LAFIYAParticipants will be young sexual minority men (YSMM) and providers from healthcare institutions working with YSMM. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- YSMM: To be eligible to participate in the interview, the person must be between 18 to 25 years old, have no experience using unassisted HIVST kits, do not know their HIV status or tested negative, currently identifies as cis-gender man, and have had sex with another man within six months before engaging with the recruitment team and must reside within a slum community in the Greater Accra Metropolitan area.
- Providers: To be eligible to participate in the interview, the person must have experience providing sexual health services such as HIV testing, counseling, and linkage to prevention and care services for at least one year. Must reside within the Greater Accra Metropolitan area and have worked with YSMM on HIV prevention and care.
Key exclusion criteria (2 listed)
- YSMM: Those who fall under 18 years or above 25 years will be excluded from the study. YSMM who have experience with unassisted HIVST kits, know their HIV status, or tested positive for HIV will be excluded from the study. YSMM who do not identify as cis-gender man and have not had sex with another man within six months before engaging with the recruitment team will be excluded from the study. YSMM who do not reside within a slum community in the Greater Accra Metropolitan area will be excluded from the study.
- Providers: Persons who do not have experience providing services such as HIV testing, counseling, and linkage to prevention and care services for at least one year will be excluded from the study. Providers not residing within the Greater Accra Metropolitan area and have not worked with YSMM on HIV prevention and care will be excluded.
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 |
|---|---|---|
| LAFIYALAFIYA will be a modified version of the Many Men Many Voices (3MV) targeted at addressing reducing stigma and increasing HIV self-testing uptake among young sexual minority men. LAFIYA will be developed into a comprehensive intervention manual for a large-scale trial using the ADAPTT-IT framework. | Behavioural | All participants |
Primary outcome
Change in percentage of participants that reported the intervention as acceptable
Time frame: Baseline to 3 months
Participants will be provided with a survey that inquires if HIVST meets their approval, meets their needs, and if they welcome the use of HIVST. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.
Change in percentage of participants that reported the intervention as appropriate
Time frame: Baseline to 3 months
Participants will be provided with a survey that inquires if HIVST seems reasonable, if HIVST seems like a good match, and if HIVST seems applicable. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.
Change in percentage of participants that reported the intervention as feasible.
Time frame: Baseline to 3 months
Participants will be provided with a survey that inquires if HIVST seems easy to use, if HIVST seems challenging, and if HIVST seems practical. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.
10 secondary outcomes
Change in the number of HIV tests
Time frame: Baseline to 3 months
Mean change in the Basic Needs Satisfaction Scale.
Time frame: Baseline to 3 months
Percentage of participants to report resilience/bouncing back after hard times.
Time frame: Baseline to 3 months
Percentage of participants that reported enacted stigma.
Time frame: Baseline to 3 months
Percentage of participants that reported vicarious stigma.
Time frame: Baseline to 3 months
Percentage of participants that reported perceived stigma.
Time frame: Baseline to 3 months
Percentage in participants that reported internalized stigma.
Time frame: Baseline to 3 months
Percentage of participants that reported stigma for involving in same sex relations.
Time frame: Baseline to 3 months
Percentage of participants that reported stigma from being gender non-conforming.
Time frame: Baseline to 3 months
Healthcare climate
Time frame: Baseline to 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 11 Jun 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAFIYA in people with HIV Prevention and Care, run by University of Rochester at 1 site in Ghana.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. 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 Ghana. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percentage of participants that reported the intervention as acceptable (time frame: Baseline to 3 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?
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 11 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.