CompletedPhase 1

Our Family Our Future: Acceptability and Feasibility Study of a Family Prevention Program for HIV Risk and Depression

South Africa146 participantsStarted 2015-05

Plain-language summary

The purpose of this study is to assess the feasibility and acceptability of a family-based preventive intervention designed to reduce sexual risk behaviors and depressive symptoms among South African adolescents and their parents/guardians/caregivers.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18+ years
. primary caregiver or the person responsible for childcare in the household on a day to day basis (as identified by the household);
. when more than one primary caregiver exists in the household, one will be chosen at random;
. lives in the household at least 4 days a week
. sub clinical thresholds of depressive symptoms
. 13-15 years;
. concurs that the adult identified is their primary caregiver;
. when more than one child in the family falls within the eligible age range, one child will be chosen at random;

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention

Timeframe: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

Change or maintenance of depressive symptoms at sub-clinical range from baseline to 4 months post-intervention measured by CES-D and CES-DC

Timeframe: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

Intervention acceptability - satisfaction with intervention content, delivery, length using the client satisfaction questionnaire and as measured on a likert scale response and as open-ended response options

Timeframe: acceptability will be assessed during the intervention, an expected average timeframe of 4 weeks

Intervention feasibility measured by attendance, retention for outcome assessments, fidelity

Timeframe: cceptability will be assessed during the intervention, an expected average timeframe of 4 weeks

Trial details

NCT IDNCT02432352

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-07-31

View on ClinicalTrials.gov More Sexual Behavior trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 18+ years
. primary caregiver or the person responsible for childcare in the household on a day to day basis (as identified by the household);
. when more than one primary caregiver exists in the household, one will be chosen at random;
. lives in the household at least 4 days a week
. sub clinical thresholds of depressive symptoms
. 13-15 years;
. concurs that the adult identified is their primary caregiver;
. when more than one child in the family falls within the eligible age range, one child will be chosen at random;

Exclusion criteria

What they're measuring

Change from baseline in sexual behavior or intended sexual behavior at 4 months post-intervention

Timeframe: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

Change or maintenance of depressive symptoms at sub-clinical range from baseline to 4 months post-intervention measured by CES-D and CES-DC

Timeframe: assessed at baseline, starting within 2-4 weeks of intervention end, and 4 months post-intervention

Timeframe: acceptability will be assessed during the intervention, an expected average timeframe of 4 weeks

Intervention feasibility measured by attendance, retention for outcome assessments, fidelity

Timeframe: cceptability will be assessed during the intervention, an expected average timeframe of 4 weeks