Developing a Dyadic Intervention for Sexually Transmitted Infection (STI)/HIV Prevention in Youth
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03275168|
Recruitment Status : Recruiting
First Posted : September 7, 2017
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Exposure to Sexually Transmissible Disorder (Event)||Behavioral: Intervention Behavioral: Individual evidence-based STI/HIV prevention intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||Single blind|
|Official Title:||Developing a Dyadic Intervention for STI/HIV Prevention in Youth|
|Actual Study Start Date :||January 15, 2018|
|Estimated Primary Completion Date :||November 1, 2019|
|Estimated Study Completion Date :||November 1, 2020|
Active Comparator: Control
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention
Behavioral: Individual evidence-based STI/HIV prevention intervention
Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
Other Name: Sister to Sister / Focus on the Future
Participants will receive individual evidence-based STI/HIV prevention intervention (Sister to Sister Teen for female participants and Focus on the Future for male participants) for STI prevention plus dyadic counseling and negotiation practice with partner
Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
- Feasibility [ Time Frame: 24 months ]Recruitment (as a measure of feasibility) will be assessed by calculating the proportion of eligible patients who return with a partner to the study appointment and proportion of dyads who consent to participate in the study.
- Acceptability [ Time Frame: 24 months ]Recruitment (as a measure of feasibility) will be assessed by calculating the proportion of eligible patients who return with a partner to the study appointment and proportion of dyads who consent to participate in the study. Retention for the 6-8 week interview will also be calculated as a measure of acceptability.
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): NCT03275168
|Contact: Steven Huettner, BSemail@example.com|
|United States, Maryland|
|Johns Hopkins Medicine||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Julia Rowell, BA 443-287-1140 firstname.lastname@example.org|
|Contact: Steven Huettner, BA 4103022103 email@example.com|
|Principal Investigator:||Maria E Trent, MD, MPH||Johns Hopkins University|