Status:
COMPLETED
Couple User Preferences in Dual Purpose Prevention Products
Lead Sponsor:
Microbicide Trials Network
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
HIV Prevention
Contraception Behavior
Eligibility:
All Genders
18-40 years
Brief Summary
MTN-045 is a cross-sectional study that will utilize questionnaires, including Discrete-Choice Experiments (DCE) and joint decision tasks, to assess couples' preferences related to dual purpose preven...
Detailed Description
MTN-045 is a cross-sectional study that will utilize questionnaires, including DCEs and joint decision tasks, and IDIs to assess heterosexual couples' preferences related to DPP products that could be...
Eligibility Criteria
Inclusion
- Each member of the couple must meet all of the following criteria to be eligible for inclusion in the study, and both members of the couple must be willing and eligible for the couple to enroll:
- Able and willing to provide written informed consent in one of the study languages.
- Able and willing to complete the required study procedures.
- Currently in a heterosexual relationship (living together or not) for at least 3 months (by self-report) with the other member of the couple.
- At time of Enrollment, expressed interest in contraception and/or HIV prevention (by self-report).
- For female partner:
- Between the ages of 18 to 40 years (inclusive) at Enrollment, verified per site standard operating procedures (SOPs).
- HIV negative (by self-report).
- For male partner:
- Aged 18 years or older at Enrollment, verified per site SOPs.
Exclusion
- Potential participants who meet the following criteria will be excluded from the study along with their partner:
- 1\. Has any significant medical condition or other condition that, in the opinion of the Investigator of Record (IoR)/designee, would preclude informed consent, make study participation unsafe (including risk for IPV as a result of study participation), complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Key Trial Info
Start Date :
January 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 5 2020
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT04023799
Start Date
January 21 2020
End Date
November 5 2020
Last Update
October 13 2022
Active Locations (2)
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1
Makerere University - Johns Hopkins University (MU-JHU) Research
Kampala, Uganda
2
Zengeza Clinical Research Site
Harare, Zimbabwe