Ignite Creation Date:
2024-05-06 @ 7:05 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05882916
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-05-18
Brief Title:
Reaching the Last 20 the Pamoja Kwa Afya Study
Sponsor:
Sue Napierala
Organization:
RTI International
Study Overview
Official Title:
Reaching the Last 20 a Targeted HIV Self-test Secondary Distribution Intervention to Engage High-risk Men in Kenya
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 mens 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 interventions 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
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 interventions 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None