At a glance
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UNCPMZ 41901 - An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women: a Pilot Study
In Brief
A clinical study evaluating iNSC and Adherence supporter training for HIV-1-infection and Antenatal Care. Completed, enrolled 300 participants across 1 site.
Detailed Summary
This study is composed of two parallel, pilot randomized groups that will obtain preliminary data about the the acceptability, fidelity, and clinical outcomes associated with a multi-component adherence support strategy for HIV treatment and prevention among pregnant and breastfeeding women. The study will take place in Lilongwe, Malawi.
Study Details
Timeline
Interventions
Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence. Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence.