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Trial record 42 of 178 for:    chlamydia infection | "Sexually Transmitted Diseases"

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

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ClinicalTrials.gov Identifier: NCT03231358
Recruitment Status : Not yet recruiting
First Posted : July 27, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborators:
University of Cape Town
Desmond Tutu HIV Centre
Medical Research Council, South Africa
Rhode Island Hospital
Information provided by (Responsible Party):
Caroline Kuo, 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.

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Depression Sexually Transmitted Diseases Behavioral: Our Family Our Future Phase 3

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  (Clinical Trial)
Estimated Enrollment : 880 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Our Family Our Future: A Resilience-oriented Family Intervention to Prevent Adolescent HIV/STI Infection and Depression in South Africa
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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).



Primary Outcome Measures :
  1. incidence of composite HIV/STIs [ Time Frame: 12 months ]
    We will examine whether the intervention produces reductions in HIV and STI incidence using biological tests for HIV, Chlamydia trachomatis, and Neisseria gonorrhoeae.

  2. rates of sexual risk behavior [ Time Frame: 12 months ]
    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.

  3. depressive symptoms [ Time Frame: 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 - Child Version (CES-DC)


Secondary Outcome Measures :
  1. Resilience [ Time Frame: 12 months ]
    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.

  2. protective sex behavioral skills [ Time Frame: 12 months ]
    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.

  3. self efficacy for protective behavioral skills [ Time Frame: 12 months ]
    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.

  4. intolerant or tolerant attitudes relating to sex, condom use, and gender equitable relationships [ Time Frame: 12 months ]
    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.

  5. intolerant or tolerant social norms relating to sex, condom use, and gender equitable relationships [ Time Frame: 12 months ]
    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.

  6. family communication [ Time Frame: 12 months ]
    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.

  7. access to social support [ Time Frame: 12 months ]
    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.

  8. Sociodemographic characteristics of the participant [ Time Frame: 12 months ]
    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.

  9. Sociodemographic characteristics of the parent [ Time Frame: 12 months ]
    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.

  10. Severity of parental depressive symptoms [ Time Frame: 12 months ]
    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.

  11. presence of HIV in the family [ Time Frame: 12 months ]
    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. orphanhood of adolescent participant [ Time Frame: 12 months ]
    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.

  13. presence of food insecurity [ Time Frame: 12 months ]
    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.

  14. receipt of social protection grants [ Time Frame: 12 months ]
    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.


Other Outcome Measures:
  1. treatment fidelity [ Time Frame: 12 months ]
    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.

  2. intervention optimization [ Time Frame: 12 months ]
    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.

  3. intervention satisfaction [ Time Frame: 12 months ]
    We examine how much participants like and dislike the intervention by gathering satisfaction data using likert scales on open responses.



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Ages Eligible for Study:   14 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 (<8) or clinically significant thresholds of depression (16+)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03231358


Locations
United States, Rhode Island
Caroline Kuo Not yet recruiting
Providence, Rhode Island, United States, 02906
Contact: Caroline Kuo, DPhil, MPhil    401 863 5453    caroline_kuo@brown.edu   
Principal Investigator: Linda-Gail Bekker, MBChB, FCP, PhD         
Principal Investigator: Dan J Stein, MBChB, FRCPC, PhD         
Sub-Investigator: Millicent Atujuna, PhD         
Sub-Investigator: Catherine Mathews, PhD         
Sub-Investigator: Tao Liu, PhD         
Sub-Investigator: Larry K Brown, MD         
Sponsors and Collaborators
Brown University
University of Cape Town
Desmond Tutu HIV Centre
Medical Research Council, South Africa
Rhode Island Hospital

Responsible Party: Caroline Kuo, Assistant Professor, Brown University
ClinicalTrials.gov Identifier: NCT03231358     History of Changes
Other Study ID Numbers: R01MH114843 ( U.S. NIH Grant/Contract )
First Posted: July 27, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases, Viral
Infection
Depression
Depressive Disorder
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
Behavioral Symptoms
Mood Disorders
Mental Disorders
Immune System Diseases
Virus Diseases
Slow Virus Diseases
Genital Diseases, Male
Genital Diseases, Female