Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Primary Purpose
Human Immunodeficiency Virus, Depression, Sexually Transmitted Diseases
Status
Active
Phase
Phase 3
Locations
South Africa
Study Type
Interventional
Intervention
Our Family Our Future
Sponsored by
About this trial
This is an interventional prevention trial for Human Immunodeficiency Virus
Eligibility Criteria
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+)
Sites / Locations
- Masiphumelele
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
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.
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.
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)
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03231358
First Posted
July 21, 2017
Last Updated
May 11, 2023
Sponsor
Brown University
Collaborators
University of Cape Town, Desmond Tutu HIV Foundation, Medical Research Council, South Africa, Rhode Island Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03231358
Brief Title
Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Official Title
Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 21, 2018 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brown University
Collaborators
University of Cape Town, Desmond Tutu HIV Foundation, Medical Research Council, South Africa, Rhode Island Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus, Depression, Sexually Transmitted Diseases
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
We will randomize adolescents (with parents) 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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
880 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Our Family Our Future
Intervention Description
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.
Primary Outcome Measure Information:
Title
incidence of composite HIV/STIs
Description
We will examine whether the intervention produces reductions in HIV and STI incidence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae.
Time Frame
12 months
Title
rates of sexual risk behavior
Description
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.
Time Frame
12 months
Title
depressive symptoms
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Resilience
Description
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.
Time Frame
12 months
Title
protective sex behavioral skills
Description
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.
Time Frame
12 months
Title
self efficacy for protective behavioral skills
Description
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.
Time Frame
12 months
Title
intolerant or tolerant attitudes relating to sex, condom use, and gender equitable relationships
Description
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.
Time Frame
12 months
Title
intolerant or tolerant social norms relating to sex, condom use, and gender equitable relationships
Description
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.
Time Frame
12 months
Title
family communication
Description
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.
Time Frame
12 months
Title
access to social support
Description
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.
Time Frame
12 months
Title
Sociodemographic characteristics of the participant
Description
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.
Time Frame
12 months
Title
Sociodemographic characteristics of the parent
Description
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.
Time Frame
12 months
Title
Severity of parental depressive symptoms
Description
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.
Time Frame
12 months
Title
presence of HIV in the family
Description
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.
Time Frame
12 months
Title
orphanhood of adolescent participant
Description
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.
Time Frame
12 months
Title
presence of food insecurity
Description
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.
Time Frame
12 months
Title
receipt of social protection grants
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
treatment fidelity
Description
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.
Time Frame
12 months
Title
intervention optimization
Description
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.
Time Frame
12 months
Title
intervention satisfaction
Description
We examine how much participants like and dislike the intervention by gathering satisfaction data using likert scales on open responses.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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+)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Kuo, DPhil, MPhil
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Linda-Gail Bekker, MBChB, PhD
Organizational Affiliation
Desmond Tutu HIV Foundation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dan J Stein, MBChB, PhD
Organizational Affiliation
University of Cape Town
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masiphumelele
City
Cape Town
State/Province
Western Cape
ZIP/Postal Code
7975
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
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