EMOTION increases uptake and correct and consistent use of ARV-based HIV prevention products by women at high risk of HIV infection using an end-user centered strategy.
Project VOGUE underway. EMOTION is currently preparing for Project VOGUE, a socio-behavioral study comparing the human-centered design (HCD)-branded experience and product to unbranded product and standard of care, using objective markers of adherence. This is an open-label, staggered enrollment study in healthy, young (18- to 25-year olds), non-pregnant, HIV uninfected women, who are not at risk of pregnancy. Participants assigned to the control arm and the intervention arm will undergo the same number of visits and assessments. In an effort to reduce contamination between the control arm participants and intervention arm participants, recruitment of the control arm will begin first. Once a sufficient number of participants have completed the control arm, recruitment for the intervention arm will begin. This study will be conducted at MatCH Research Unit (MRU) in Durban. Approval from HREC (local IRB) has been received for this study.
All participants will be screened for participation in the study based on current guidelines for oral PrEP implementation. The control arm will receive oral PrEP, dispensed in accordance with current WHO and South African HIV Clinicians Society Guidelines. The intervention arm will receive oral PrEP in accordance with current guidelines, but the oral PrEP will come in branded starter package, with attendant adherence support. During enrollment of the intervention arm, the MRU site clinic will also be supplied with branded materials to help enhance participant understanding of oral PrEP and adherence to oral PrEP and to assist health care providers in explaining the benefits and risks of taking oral PrEP. Up to 300 women will be screened. so that 75 participants in each arm complete all study visits. All participants will take oral TDF/FTC daily for approximately three months, in accordance with current guidelines for the administration of oral PrEP. All components of the intervention arm are currently being prepared.
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