CHARISMA Expansion Study

NACompletedINTERVENTIONAL
Enrollment

407

Participants

Timeline

Start Date

October 15, 2018

Primary Completion Date

May 25, 2020

Study Completion Date

May 25, 2020

Conditions
Relationship DynamicsPre-exposure Prophylaxis (PrEP) Adherence
Interventions
OTHER

Control

Standard of care (SOC) HIV prevention services in line with the South African DoH (Department of Health) PrEP (Pre-exposure Prophylaxis) rollout program that include daily oral TDF/FTC (tenofovir disoproxil fumarate/emtricitabine). In addition, risk reduction counseling, IPV (Intimate Partner Violence) screening using the VAWS (WHO Violence Against Women Survey) with referrals for counseling, medical care, or shelter assistance, among other care options, if needed and an informational packet regarding HIV prevention services for themselves and male partners will be offered

BEHAVIORAL

CHARISMA Intervention

"SOC (Standard of Care) per control arm plus provider-administration of HEART and provider-administration of CHARISMA counseling modules, as applicable:~* Module A: General Partner Communication and Relationship Skills~* Module B: Partner Disclosure and Communication around PrEP Use~* Module C: Responding to Intimate Partner Violence and Safety Planning"

Trial Locations (1)

2001

Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg

All Listed Sponsors
collaborator

Wits Reproductive Health and HIV Institute

OTHER

collaborator

FHI 360

OTHER

collaborator

United States Agency for International Development (USAID)

FED

lead

RTI International

OTHER

NCT04092114 - CHARISMA Expansion Study | Biotech Hunter | Biotech Hunter