Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05374109
Status:
RECRUITING
Last Update Posted:
2023-12-18
First Post:
2022-05-06
Brief Title:
SYV A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
SYV A Mental Health Intervention to Improve HIV Outcomes in Tanzanian Youth
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The overall objectives of this proposal are to support positive coping strategies that bolster mental health and lead to improved HIV outcomes among Young People Living with HIV YPLWH The central hypothesis is that SYV Sauti ya Vijana The Voice of Youth will be effective to improve antiretroviral therapy ART adherence and virologic suppression in YPLWH in Tanzania The rationale for this project is that by targeting mental health which is strongly associated with medication adherence that this will effectively improve adherence and thereby HIV viral suppression The central hypothesis will be tested in three aims in a hybrid type-1 effectiveness-implementation trial
Detailed Description:
The rigorous experimental design includes a pilot study followed by a parallel-arm randomized control trial RCT The pilot will include approximately eight consenting members of the youth community advisory board CAB at each site location prior to the RCT If a youth CAB does not currently exist at each site one will be formed Although the investigators have strong pilot data for the SYV intervention from Moshi the pilot test proposed herein will help ensure recruitment enrollment intervention delivery supervision measurement technology and logistics run as expected at each site Moshi Mbeya Mwanza Ifakara The pilot study will be comprised of 8 participants recruited at each site Subsequently for the RCT we will individually randomize up to 750 participants to receive the SYV intervention or SOC standard of care to achieve 90 power to detect a 10 percentage point difference between arms in the primary outcome of virologic suppression at the two-tailed 5 significance level accounting for clustering by SYV group in the intervention arm
The intervention will be rolled out across four main sites in four different Tanzanian regions and in four waves separated in time by 6 months There will be two SYV groups per wave at each site 8 groups per site A study visit for all participants will be conducted baseline and approximately 4 months T1 6- 12- and 18-months post-baseline T2 T3 T4 with 6-months post baseline being the primary endpoint At 12 months post-baseline T3 those randomized to the SYV intervention will receive a one-session SYV booster to improve content retention and study engagement as has been shown in prior studies
The intervention will be rolled out across four main sites in four different Tanzanian regions and in four waves separated in time by 6 months There will be two SYV groups per wave at each site 8 groups per site A study visit for all participants will be conducted baseline and approximately 4 months T1 6- 12- and 18-months post-baseline T2 T3 T4 with 6-months post baseline being the primary endpoint At 12 months post-baseline T3 those randomized to the SYV intervention will receive a one-session SYV booster to improve content retention and study engagement as has been shown in prior studies
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 |
|---|---|---|---|
| 1R01MH124476-01A1 | NIH | None | httpsreporternihgovquickSearch1R01MH124476-01A1 |