Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05769270
Status:
TERMINATED
Last Update Posted:
2023-03-29
First Post:
2023-03-02
Brief Title:
Development of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black MSM
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Development and Pilot RCT of a Telehealth-delivered Peer Navigation and Coping Skills Intervention to Increase PrEP Use in Young Black Men Who Have Sex With Men
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator requested early termination of grant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This proposal seeks to adapt an existing peer navigation protocol by adding coping skills and using telehealth to be feasible acceptable and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24
Detailed Description:
Young Black men who have sex with men YBMSM ages 15-24 are heavily affected by HIV transmission and at current rates nearly half of Black MSM in the US will be infected with HIV in their lifetime MSM represented 42 of all HIV diagnoses in Massachusetts from 2015-2017 and rates among Black MSM were 7 times that of White MSM Fortunately PrEP is highly effective at preventing HIV if adhered to in a prevention-effective P-E manner which involves daily or event-based dosing specifically during periods of risk of HIV exposure ie P-E adherence Unfortunately initiation and adherence among YBMSM is lower than other racial and age groups According to Social Action Theory barriers among YBMSM can be conceptualized as multifactorial consisting of contextual factors eg moodarousal factors structural factors and demographics and self-change processes social interaction processes motivations generative capabilities and problem-solving skills An effective intervention must address contextual and self-change processes to promote PrEP uptake and P-E adherence
The use of navigators ie health workers trained to support ongoing adherence has shown promise in promoting both PrEP uptake and sustained use in Black MSM by addressing structural barriers however rates of PrEP discontinuation were high An NICHD-funded U01 study SMILE conducted in Boston found that peer navigation was highly acceptable for youth with HIV The current study will use the Boston site of SMILEs peer navigation protocol Notably SMILE did not include behavioral components In addition to structural barriers YBSM often face unique barriers such as medical mistrust and disclosure concerns that affect self-change processes and impede PrEP uptake and P-E adherence Limited knowledge exists on how these factors may impede PrEP use however it is clear these barriers may be addressed using problememotion-focused coping strategies Many PrEP interventions require office visits which may limit participation to those willing and able to present to a research office Despite prevalent economic stressors more than 90 of YMSM of color in various studies have smartphones thus telehealth and remote study procedures may facilitate participation by YBMSM at highest HIV risk This proposal seeks to adapt peer navigation from SMILE adding coping skills and using telehealth to be feasible acceptable and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24
Aim 1 Obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting PrEP uptake and P-E adherence I will conduct 30 in-depth interviews with YBMSM at various stages of the PrEP continuum eg never used former user and currently using PrEP using a semi-structured interview guide Interviews will explore how contextual factors and self-change processes influence PrEP uptake and P-E adherence It will specify the role of a peer navigator eg meeting frequency demographics of navigator topics to discuss and how best to employ technology-based tools and strategies The knowledge gained from these interviews will be used to inform intervention development in Aim 2
Aim 2 Develop and iteratively refine the intervention in consultation with a Youth Advisory Board Intervention development will be guided by Aim 1 findings and the IDEAS framework ie generating ideas for intervention strategies developing an initial intervention gathering user feedback and creating a viable intervention We will recruit 20 YBMSM via online and in-person strategies to participate in an advisory board meeting quarterly virtually or in-person to provide feedback on the intervention The intervention will be iteratively refined after each meeting resulting in a refined intervention manual for use in the Aim 3 trial
Aim 3 Evaluate the telehealth-delivered peer navigationcoping skills intervention for feasibility and acceptability We will have a short 3-month run-in of the intervention with 2-4 sexually active YBMSM without HIV ages 15-24 After further refinement we will conduct a small N60 RCT of the peer navigationcoping skills intervention vs treatment as usual TAU PrEPcase management referrals The primary outcomes will be feasibility and acceptability Secondarily we will examine group differences in PrEP uptake P-E adherence proportion of covered sexual episodes and sustained use at 6 months among those with risk Outcomes of this aim will be a feasible 75 enrollment 75 of sessions attended and acceptable per questionnaires and exit interviews intervention that can be tested in a larger efficacy trial in the context of a future R01 grant
The use of navigators ie health workers trained to support ongoing adherence has shown promise in promoting both PrEP uptake and sustained use in Black MSM by addressing structural barriers however rates of PrEP discontinuation were high An NICHD-funded U01 study SMILE conducted in Boston found that peer navigation was highly acceptable for youth with HIV The current study will use the Boston site of SMILEs peer navigation protocol Notably SMILE did not include behavioral components In addition to structural barriers YBSM often face unique barriers such as medical mistrust and disclosure concerns that affect self-change processes and impede PrEP uptake and P-E adherence Limited knowledge exists on how these factors may impede PrEP use however it is clear these barriers may be addressed using problememotion-focused coping strategies Many PrEP interventions require office visits which may limit participation to those willing and able to present to a research office Despite prevalent economic stressors more than 90 of YMSM of color in various studies have smartphones thus telehealth and remote study procedures may facilitate participation by YBMSM at highest HIV risk This proposal seeks to adapt peer navigation from SMILE adding coping skills and using telehealth to be feasible acceptable and capable of supporting both PrEP uptake and P-E adherence for YBMSM ages 15-24
Aim 1 Obtain qualitative knowledge on experiences of YBMSM ages 15-24 and specify role of peer navigator in promoting PrEP uptake and P-E adherence I will conduct 30 in-depth interviews with YBMSM at various stages of the PrEP continuum eg never used former user and currently using PrEP using a semi-structured interview guide Interviews will explore how contextual factors and self-change processes influence PrEP uptake and P-E adherence It will specify the role of a peer navigator eg meeting frequency demographics of navigator topics to discuss and how best to employ technology-based tools and strategies The knowledge gained from these interviews will be used to inform intervention development in Aim 2
Aim 2 Develop and iteratively refine the intervention in consultation with a Youth Advisory Board Intervention development will be guided by Aim 1 findings and the IDEAS framework ie generating ideas for intervention strategies developing an initial intervention gathering user feedback and creating a viable intervention We will recruit 20 YBMSM via online and in-person strategies to participate in an advisory board meeting quarterly virtually or in-person to provide feedback on the intervention The intervention will be iteratively refined after each meeting resulting in a refined intervention manual for use in the Aim 3 trial
Aim 3 Evaluate the telehealth-delivered peer navigationcoping skills intervention for feasibility and acceptability We will have a short 3-month run-in of the intervention with 2-4 sexually active YBMSM without HIV ages 15-24 After further refinement we will conduct a small N60 RCT of the peer navigationcoping skills intervention vs treatment as usual TAU PrEPcase management referrals The primary outcomes will be feasibility and acceptability Secondarily we will examine group differences in PrEP uptake P-E adherence proportion of covered sexual episodes and sustained use at 6 months among those with risk Outcomes of this aim will be a feasible 75 enrollment 75 of sessions attended and acceptable per questionnaires and exit interviews intervention that can be tested in a larger efficacy trial in the context of a future R01 grant
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K23MH129240 | NIH | None | httpsreporternihgovquickSearch1K23MH129240 |