Clinical trial NCT07002866: Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
Official title: Suubi4PrEP: Improving PrEP Access and Adherence Among Adolescent Girls and Young Women in Uganda
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Prevention
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Columbia University
First posted: 2025-06-04
Enrollment: 600
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Age 15-24 years
2. At a high risk of HIV. AGYW will be deemed to be at substantial risk, and eligible to participate in the study, if they report at least one of the seven high-risk sexual behaviors on the risk assessment tool: 1) vaginal/anal sexual intercourse with more than one partner of unknown HIV status in the past six months, 2) vaginal/anal sex without a condom in the past six months, 3) sex in exchange for money, goods or a service in the last six months, 4) injecting drugs in the past six months, 5) diagnosis with an STI more than once in the past twelve months, 6) post-exposure prophylaxis (PEP) for sexual exposure to HIV in the past six months, and 7) having an HIV-infected sexual partner who was not on ART.

Exclusion Criteria:

1. HIV positive
2. Unable to understand the study procedures and/or participant rights during the informed consent process
3. Unwilling or unable to commit to completing the study

Primary outcomes:
measure: PrEP Initiation
timeFrame: Baseline, 12, 24 and 36 months
Secondary outcomes:
measure: PrEP Adherence
timeFrame: Baseline, 12, 24, 36 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Masaka
country: Uganda
facility: International Center for Child Health and Development (ICHAD)
Study officials:
References: