Study Summary
This trial will test a couples-based HIV prevention program to see if it can reduce the risk of HIV transmission for transgender women and their partners.
Eligible Conditions
- Human Immunodeficiency Virus (HIV) Infection
- Primary HIV Infection
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: Changes in CR-HIV at 12-month follow-up
Changes in CR-HIV at 12-month follow-up
Composite Risk for HIV
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Control
1 of 2
Intervention
1 of 2
Active Control
Experimental Treatment
240 Total Participants · 2 Treatment Groups
Primary Treatment: CHIP · No Placebo Group · N/A
Intervention
Behavioral
Experimental Group · 1 Intervention: CHIP · Intervention Types: BehavioralControl
Behavioral
ActiveComparator Group · 1 Intervention: Control · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: changes in cr-hiv at 12-month follow-up
Who is running the clinical trial?
University of California, San FranciscoOTHER
2,285 Previous Clinical Trials
11,577,677 Total Patients Enrolled
Brown UniversityOTHER
416 Previous Clinical Trials
519,117 Total Patients Enrolled
University of MichiganLead Sponsor
1,634 Previous Clinical Trials
6,415,034 Total Patients Enrolled
Ellen SteinStudy DirectorUniversity of California, San Francisco
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You must be able to speak and read English.
You are in a romantic relationship for at least three months.
References
- Sevelius, Jae M., Luis Gutierrez-Mock, Sophia Zamudio-Haas, Breonna McCree, Azize Ngo, Akira Jackson, Carla Clynes, et al.. 2020. “Research with Marginalized Communities: Challenges to Continuity During the COVID-19 Pandemic”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-020-02920-3.
- Gamarel, Kristi E, Jae M Sevelius, Torsten B Neilands, Rachel L Kaplan, Mallory O Johnson, Tooru Nemoto, Lynae A Darbes, and Don Operario. 2020. “Couples-based Approach to HIV Prevention for Transgender Women and Their Partners: Study Protocol for a Randomised Controlled Trial Testing the Efficacy of the ‘it Takes Two’ Intervention”. BMJ Open. BMJ. doi:10.1136/bmjopen-2020-038723.
- Gamarel, Kristi E., Deepalika Chakravarty, Torsten B. Neilands, Colleen C. Hoff, James Lykens, and Lynae A. Darbes. 2018. “Composite Risk for HIV: A New Approach Towards Integrating Biomedical and Behavioral Strategies in Couples-based HIV Prevention Research”. AIDS and Behavior. Springer Science and Business Media LLC. doi:10.1007/s10461-018-2229-8.
- Sevelius JM, Gutierrez-Mock L, Zamudio-Haas S, McCree B, Ngo A, Jackson A, Clynes C, Venegas L, Salinas A, Herrera C, Stein E, Operario D, Gamarel K. Research with Marginalized Communities: Challenges to Continuity During the COVID-19 Pandemic. AIDS Behav. 2020 Jul;24(7):2009-2012. doi: 10.1007/s10461-020-02920-3. No abstract available.
- Kristi Gamarel 2019. "A Couples-based Intervention for Transgender Women and Their Partners". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04067661.
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Conditions
Cancer Related
Treatments