N/A Completed N=1,260 Randomized Double-blind Prevention

Suubi4Her: Combination Intervention for Adolescent Girls Transitioning Into Adulthood in Uganda

HIV

Source: ClinicalTrials.gov NCT03307226 ↗

Enrolled (actual)

1,260

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcomePrimary: Proportion With STIs From Baseline to Follow-up Assessments — 43; 20; 29; 428 Participants

Summary

This study examines the impact and cost associated with Suubi4Her, an innovative combination intervention that aims to prevent HIV risk behaviors among 15-17 year-old girls living in communities heavily affected by poverty and HIV/AIDS in Uganda. Participants will be randomly assigned at the school level into one of three study conditions: 1) Savings (Youth Development Accounts - YDA) - with a 1:1 incentive match rate - for education and microenterprise development; 2) Savings (YDA) + Multiple Family Groups intervention; 3) Control condition receiving standard health and sex education provided in schools. The intervention will last for 24 months. Assessments will be conducted at baseline, 12, 24 and 36 months. Assessments will include biologically confirmed STIs, proportion of HIV infections during the study period, and for HIV+ participants markers for ART adherence. The study aims to examine the impact of the Suubi4Her intervention on behavioral health functioning, and protecting adolescent girls against known HIV risk factors. The study will also examine the cost-effectiveness of each intervention condition.

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion With STIs From Baseline to Follow-up Assessments	22; 22; 15; 435; 344; 381	—
SECONDARY Proportion Positive for HIV Infections at Each Assessment Time Point (Baseline, 12-, 24-follow-up)	4; 2; 4; 453; 364; 392	—
SECONDARY Change in Adherence to HIV Treatment From Baseline to Follow-up Assessments	—	—
SECONDARY Cost-Effectiveness Analyses	—	—

Eligibility Criteria

Inclusion Criteria

(1) female; (2) enrolled in first year of secondary school in Rakai, Masaka, Lwengo or Kalungu districts; (3) age 14-17 years; (4) living within a family (broadly defined and not an institution or orphanage, as those in institutions have different familial needs)

Exclusion Criteria

(5) they have a cognitive or severe psychiatric impairment that would prevent comprehension of study procedures as assessed during the Informed Consent process or; (6) they are unwilling or unable to commit to completing the study.

We will not exclude girls because of their HIV, STI and/or pregnancy status. Analysis will be adjusted to account for these baseline factors. Girls testing positive for HIV, STI or pregnancy will be referred for care and support.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03307226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.