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

Phase 3

Completed

Conditions: Human Immunodeficiency Virus
Depression
Sexually Transmitted Diseases

Interventions: Behavioral: Our Family Our Future

Registration Number: NCT03231358

Lead Sponsor: Brown University

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.

Detailed Description: Adolescent human immunodeficiency virus (HIV) and depression present significant public health challenges for South Africa, a country with the largest HIV epidemic globally and where structural factors including violence and poverty increase susceptibility for poor mental health. In families already experiencing psychological distress, adolescents face elevated risk for sexually transmitted infections (STIs) including HIV and depression. Preventive interventions are urgently needed during adolescence when risks for HIV, STIs, and depression in-crease exponentially. Preventive intervention strategies for adolescents should substantively involve families who can tailor prevention content to meet the unique needs of individual adolescents and reinforce formation and habituation of prevention behaviors. Moreover, evidence indicates common family risk and protective factors for adolescent HIV/STI risk behaviors and depression, underscoring the need for a family prevention approach. However, key gaps exist in family prevention science. In South Africa, few empirically supported family interventions integrate prevention of HIV/STI with depression for adolescents. This intervention (called Our Family Our Future) uses a resilience-oriented approach engages families in adolescent prevention from low-resource settings facing high adversity. The study will focus on adolescents (14-16 years) who are at an ideal developmental transition for family engagement in prevention. The age- and developmentally-tailored intervention - called Our Family Our Future - is based off of two empirically supported interventions that have been integrated and adapted to South Africa. In a pilot randomized trial, Our Family Our Future exhibited outstanding acceptability, feasibility and promising direction of effects including reductions of depressive symptoms; lower rates of sex; decreased unprotected sex; increased HIV testing; increased knowledge, motivation, intentions and self-efficacy for protective HIV/STI behaviors; improved family interactions; and increased resilience. Now investigators propose the next phase of this research program, an efficacy study of Our Family Our Future with three aims: (1) test the efficacy of the Our Family Our Future intervention in preventing HIV/STI acquisition among adolescents (14-16) with depressive symptoms by reducing HIV/STI risk behavior, and reducing depressive symptoms. The project will randomize N=880 adolescents to Our Family Our Future intervention or usual care with 6- and 12-month outcome assessments; (2) examine the extent to which the impact of the Our Family Our Future intervention is a) mediated by changes in resilience; behavioral skills; norms and attitudes relating to sex, condom use, gender; and family communication and functioning and b) moderated by the effect of sociodemographics, family HIV, and social protections; (3) identify barriers and facilitators to implementing Our Family Our Future within a large community-based organization setting with wide reach to provide data for future dissemination and scale-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1758

Inclusion Criteria

14-16 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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Our Family Our Future	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 involving adolescent-parent dyads, delivered in a group setting over 3-4 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Depressive Symptoms	12 months	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.
Prevalence of HIV and/or Chlamydia and/or Gonorrhoeae	12 months	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).
Number of Participants Engaged In Vaginal Sex	12 months	We will examine whether the intervention produces reductions in the number of participants engaged in vaginal sex and condom use.