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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Sexually Transmitted Diseases; Human Immunodeficiency Virus
• Intervention / Treatment: Behavioral: Our Family Our Future

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.

• Study Type: Interventional
• Enrollment (Anticipated): 880
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Caroline Kuo, DPhil, MPhil; Phone Number: 401 863 5453; Email: caroline_kuo@brown.edu

Study Locations

• South Africa
  • Western Cape
    • Cape Town, Western Cape, South Africa, 7975
      • Masiphumelele

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Behavioral: Our Family Our Future; 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. This intervention involves parent-child dyads who 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.
No Intervention: Control; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of composite HIV/STIs	We will examine whether the intervention produces reductions in HIV and STI incidence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae.	12 months
rates of sexual risk behavior	We will examine whether the intervention produces reductions in rates of actual and intended sexual risk behavior, as measured through the number of unprotected sex acts.	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 - Child Version (CES-DC)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resilience	We examine whether resilience mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure resilience using a sum score on a resilience measure.	12 months
protective sex behavioral skills	We examine whether protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
self efficacy for protective behavioral skills	We examine whether self efficacy for protective sex behavioral skills - for condom use, sex refusal - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
intolerant or tolerant attitudes relating to sex, condom use, and gender equitable relationships	We examine whether attitudes around sex, condom use, and gender equity mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. These are measured through likert scales.	12 months
intolerant or tolerant social norms relating to sex, condom use, and gender equitable relationships	We examine whether intolerant or tolerant social norms around sex, condom use, and gender mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms. We measure these through likert scales.	12 months
family communication	We examine whether family communication mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
access to social support	We examine whether social support - the the form of a sum score of social support on a social support measure called the Multidimensional Scale of Perceived Social Support - mediates the the efficacy of Our Family Our Future on prevention of HIV/STI acquisition, reducing HIV/STI risk behavior, and reductions in depressive symptoms.	12 months
Sociodemographic characteristics of the participant	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the adolescent participant including gender, age, race and ethnicity.	12 months
Sociodemographic characteristics of the parent	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of sociodemographics of the parent including gender, age, race and ethnicity.	12 months
Severity of parental depressive symptoms	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of parental depressive symptoms as measured by the Center for Epidemiologic Studies Depression Scale.	12 months
presence of HIV in the family	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of family HIV including HIV infection among family members.	12 months
orphanhood of adolescent participant	We examine whether the extent of impact of the intervention on outcomes is moderated by the adolescent participant's orphanhood status answered by a self-report item asking about orphanhood status, defined as maternal or paternal or double orphanhood.	12 months
presence of food insecurity	We examine whether the extent of impact of the intervention on outcomes is moderated by the effect of structural disparities such as the presence of food insecurity. We use a likert scale measure of food insecurity.	12 months
receipt of social protection grants	We examine whether the extent of impact of the intervention on outcomes is moderated by the receipt of social protection grants as measured by self-report on whether the family receives any South African government social protection grants.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
treatment fidelity	We will gather data on treatment fidelity (what % of time the intervention facilitators abide by core elements of a standardized implementation protocol) to evaluate how rigorous the intervention is being implemented.	12 months
intervention optimization	We examine recruitment, retention, and attrition data by examining how many participants are involved in each timepoint of data collection as compared to the original number of enrolled participants.	12 months
intervention satisfaction	We examine how much participants like and dislike the intervention by gathering satisfaction data using likert scales on open responses.	12 months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Rhode Island Hospital; University of Cape Town; Medical Research Council, South Africa; Desmond Tutu HIV Foundation
• Investigators: Principal Investigator: Caroline Kuo, DPhil, MPhil, Brown University; Principal Investigator: Dan J Stein, MBChB, PhD, University of Cape Town; Principal Investigator: Linda-Gail Bekker, MBChB, PhD, Desmond Tutu HIV Foundation

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2018
• Primary Completion (Actual): August 31, 2022
• Study Completion (Anticipated): August 31, 2023

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Mood Disorders; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; Depression; Depressive Disorder; HIV Infections; Acquired Immunodeficiency Syndrome; Sexually Transmitted Diseases
• Other Study ID Numbers: R01MH114843 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No