Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa

NCT03231358 | Completed Phase 3 Results DMC

• 1 other identifier: R01MH114843
• Study Type: interventional
• Target: 1,758
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the efficacy of Our Family Our Future, an integrated intervention for preventing HIV and depression onset among adolescents.

Conditions

Human Immunodeficiency Virus; Depression; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (3)

• Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae

  We will examine whether the intervention produces reductions in HIV and STI prevalence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae. We report on the prevalence of any HIV or STI (positive for one or more of HIV and/or Chlamydia and/or Neisseria).

  12 months

• Number of Participants Engaged In Vaginal Sex

  We will examine whether the intervention produces reductions in the number of participants engaged in vaginal sex and condom use.

  12 months

• Depressive Symptoms

  We will examine whether the intervention produces reductions in depressive symptoms. Depressive symptoms will be measured through symptom scores on the Center for Epidemiologic Studies Depression Scale. Scores are summed, and range from 0 to 60. Higher scores correspond with worse depressive symptoms. There are ranges for the severity of depressive symptoms and these are as follows: 0-15: May indicate no or low levels of depressive symptoms. 16 or higher: Suggests a risk for clinically significant depressive symptoms.

  12 months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants randomized to the behavioral intervention called "Our Family Our Future." These participants will receive an intervention to prevent sexually transmitted infections (STIs) including HIV, Chlamydia trachomatis and Neisseria gonorrhoeae; sexual risk behavior; and depression onset. This is a behavioral intervention is delivered in a group setting over 3-4 consecutive weeks.

Behavioral: Our Family Our Future

Control

NO INTERVENTION

The control arm will receive usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care).

Interventions

Our Family Our Future BEHAVIORAL

Our Family Our Future is a 'selective' behavioral prevention program, designed to address HIV/STI acquisition, sexual risk behavior, and depression among adolescents (ages 14-16) in communities with high HIV prevalence and from families where adolescents and parents already exhibit mild, potentially troublesome, depressive symptoms but do not reach the threshold for further screening for a significant clinical depressive disorder. Participants receive the intervention in a community setting, in a facilitated group format. The intervention is comprised of 3-hour sessions, held weekly for 3 consecutive weeks with an individual family meeting in the third or fourth week depending on family desires.

Intervention

Eligibility Criteria

• Age: 14 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years
• adolescent concurs that the adult identified is their parent (to also include primary caregivers in the pa-rental role)
• when more than one child in the family falls within the eligible age range, one child will be chosen at random
• lives in the household at least 4 days a week

You may not qualify if:

• no or low symptoms (\<6) or clinically significant thresholds of depression (16+)

Sponsors & Collaborators

• Brown University: lead
• University of Cape Town: collaborator
• Desmond Tutu HIV Foundation: collaborator
• Medical Research Council, South Africa: collaborator
• Rhode Island Hospital: collaborator

Study Sites (1)

Masiphumelele

Cape Town, Western Cape, 7975, South Africa

Location

Related Publications (1)

• Kuo C, Wasswa J, Orchowski L, Harrison A, Liu T, Sikweyiya Y, Berkowitz A, Adrian H, Rasmeni A, Mathews C. Rationale and design of a randomized controlled trial testing the efficacy of Safe South Africa, an intervention to prevent HIV risk behavior and sexual violence among adolescent boys. Trials. 2025 Dec 8. doi: 10.1186/s13063-025-09326-3. Online ahead of print.

  PMID: 41361893 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Depression; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Caroline Kuo, DPhil, MPhil
• Organization: American University

ckuo@american.edu

2028857385

Study Officials

• Caroline Kuo, DPhil, MPhil

  Brown University

  PRINCIPAL INVESTIGATOR

• Linda-Gail Bekker, MBChB, PhD

  Desmond Tutu HIV Foundation

  PRINCIPAL INVESTIGATOR

• Dan J Stein, MBChB, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We will randomize adolescents to an intervention arm (testing Our Family Our Future, n=440) or a control arm (n=440) of usual care (consisting of a packet of existing available brochures on HIV, STIs, mental health including places to access care). We will randomize based on permuted blocked randomization.

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 27, 2017
• Study Start: November 21, 2018
• Primary Completion: August 31, 2022
• Study Completion: July 31, 2024
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-04

Locations

ZA (1)