Status:
COMPLETED
CHARISMA Expansion Study
Lead Sponsor:
RTI International
Collaborating Sponsors:
Wits Reproductive Health and HIV Institute
FHI 360
Conditions:
Relationship Dynamics
Pre-exposure Prophylaxis (PrEP) Adherence
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence...
Detailed Description
The CHARISMA Expansion Study is a two-arm, randomized (1:1), controlled study of a behavioral intervention-the Community Health clinic model for Agency in Relationships and Safer Microbicide Adherence...
Eligibility Criteria
Inclusion
- Able and willing to provide written informed consent and locator information
- Reports having a current male primary partner,
- Sexually active, defined by vaginal intercourse with a male at least 4 times per month in the past 3 months and plan to be sexually active during the study duration
- Not pregnant (defined by urine pregnancy testing) and not breastfeeding
- Not planning on becoming pregnant in the next 6 months
- English or Zulu speaking
- HIV negative based on negative HIV rapid tests, at the time of enrollment
Exclusion
- Previously participated in a clinical trial or a longitudinal HIV prevention research study
- Unwilling to use daily oral PrEP
- Has any significant medical condition or other condition that, in the opinion of the Principal Investigator (PI)/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
Key Trial Info
Start Date :
October 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2020
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT04092114
Start Date
October 15 2018
End Date
May 25 2020
Last Update
January 23 2023
Active Locations (1)
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1
Wits Reproductive Health and HIV Institute (Wits RHI)
Johannesburg, South Africa, 2001