Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-28 @ 9:29 PM
Study NCT ID:
NCT07002866
Status:
RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
Status:
RECRUITING
Status Verified Date:
2025-11
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 study will employ a multilevel combination intervention focused on PrEP initiation and adherence among adolescent girls and young women (AGYW) (aged 15-24) living in HIV hotpots in Uganda. Specifically, the study will combine: 1) HIV risk reduction (HIVRR) that incorporates sessions on PrEP, 2) Peer Supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, share strategies to address misconceptions, manage disclosure and stigma, and model positive lifestyles while engaging in care services, and 3) an economic empowerment (EE) component that includes a matched savings account and financial literacy targeting poverty and financial barriers associated with PrEP access. Working within 30 health care systems, we will randomly assign 600 AGYW (at the community level) to one of three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. The interventions will be implemented for 20 months, and data collected at baseline, 12, 24, 36 months.
Detailed Description:
Adolescent girls and young women (AGYW) aged 15-24 are twice as likely to be living with HIV than young men in Sub-Saharan Africa (SSA). HIV prevention strategies available to AGYW primarily depend on male partner cooperation, limiting the ability for these strategies to reduce HIV spread. Oral pre-exposure prophylaxis (PrEP) is a highly effective biomedical HIV prevention method. However, as effective as PrEP has been, it is underutilized. Lack of social support, disclosure concerns, stigma and discrimination, financial costs associated with transport to clinics and food to accompany medication are still major barriers. Peer support interventions and PrEP awareness via peers has been associated with increased PrEP uptake. However, these approaches may not be as effective when delivered alone -given that poverty-associated factors, too, greatly undermine PrEP access, uptake and adherence. Thus, combining multilevel interventions, in this case, combining peer support with economic empowerment (EE) targeting poverty and financial constraints, may offer additive effects to overcome these barriers. We propose a multilevel combination intervention focused on PrEP initiation and adherence among AGYW living in HIV hotpots in Uganda. Suubi(hope)4PrEP will combine: 1) HIVRR that incorporates sessions on PrEP, 2) peer supporters (PS) with lived experiences taking PrEP to facilitate linkage to and continued care, and 3) EE components targeting financial barriers associated with PrEP access. We will randomly assign 600 AGYW (at the community level) to one of the three study arms (n=200 AGYW, n=10 sites per arm): 1) HIVRR only, 2) HIVRR+ PS, or 3) HIVRR + PS + EE. Specific aims are:
Aim 1. Examine the impact of Suubi4PrEP on PrEP initiation and adherence.
Aim 2. Examine the effect of Suubi4PrEP on hypothesized mechanisms of change and intervention mediation.
Aim 3. Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.
Aim 4. Assess the cost and cost-effectiveness of the interventions.
Aim 1. Examine the impact of Suubi4PrEP on PrEP initiation and adherence.
Aim 2. Examine the effect of Suubi4PrEP on hypothesized mechanisms of change and intervention mediation.
Aim 3. Use mixed methods to explore multi-level factors that influence PrEP initiation and adherence.
Aim 4. Assess the cost and cost-effectiveness of the interventions.
Study Oversight
Has Oversight DMC:
True
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?: