Lafiya HIV Self-testing Study Protocol

NCT ID: NCT06238323

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2026-03-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Prevention and Care

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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All participants

Participants will be young sexual minority men (YSMM) and providers from healthcare institutions working with YSMM.

Group Type EXPERIMENTAL

LAFIYA

Intervention Type BEHAVIORAL

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.

Interventions

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LAFIYA

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Ghana

OTHER

Sponsor Role collaborator

George Washington University

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Gamji Rabiu Abu-Ba'are

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Ghana

Accra, , Ghana

Site Status RECRUITING

Countries

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Ghana

Central Contacts

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Gamji R Abu-Ba'are, PhD

Role: CONTACT

16077595760

Kwasi Torpey, PhD

Role: CONTACT

+233302213820

Facility Contacts

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Kwasi Torpey, PhD

Role: primary

Other Identifiers

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R01TW012671

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008385

Identifier Type: -

Identifier Source: org_study_id

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