NCT03256435

Retention in PrEP Care for African American MSM in Mississippi

Completed NA Last updated 2 December 2021

What this trial tests

NA trial testing RAMP PrEP initiation, adherence, and retention intervention in Preventive Medicine in 70 participants. Completed in 31 May 2021.

Timeline

7 September 2016

Primary endpoint
31 May 2021

31 May 2021

Quick facts

Lead sponsor	Brown University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	70
Start date	7 September 2016
Primary completion	31 May 2021
Estimated completion	31 May 2021
Sites	1 location across United States

Drugs / interventions tested

• RAMP PrEP initiation, adherence, and retention intervention

Conditions studied

• Preventive Medicine — all drugs for Preventive Medicine →
• HIV Infections — all drugs for HIV Infections →

Sponsor

Brown University

Who can join

Adults 18 to 35, male only, with Preventive Medicine or HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Innovative and novel HIV prevention interventions are urgently needed for African American (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk individuals. Although acceptability studies have demonstrated high interested in PrEP in the US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention in PrEP care in real world settings are likely more complex, since payment for PrEP can be a substantial financial burden.

The ADAPT\_ITT approach (an approach to adapting behavioral interventions to new populations: Assessment, Decision, Administration, Production, Topical Experts - Integration, Training, Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP) intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the country. This study will include formative research to understand the cultural and social contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed intervention. Results from these qualitative interviews will inform the study intervention which will be tested and refined in a dynamic open pilot evaluation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Pilot Study of a Patient Navigation Intervention to Improve HIV Pre-exposure Prophylaxis Persistence Among Black/African American Men Who Have Sex With Men.
   Goedel WC, Coats CS, Chan PA, Sims-Gomillia CE, et al · · 2022 · cited 19× · PMID 35312652 · DOI 10.1097/qai.0000000000002954