An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
- Conditions
- Antenatal CareHIV-1-infection
- Interventions
- Behavioral: iNSC and Adherence supporter training
- Registration Number
- NCT04330989
- Lead Sponsor
- University of North Carolina, Chapel Hill
- Brief 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.
- Detailed Description
If the anticipated gains for the prevention of mother-to-child HIV transmission (PMTCT) programs are to be realized, adherence to antiretroviral regimens will be critical. To date, however, there are few evidence-based approaches that are scalable and sustainable in busy, programmatic settings where HIV burden is high. The study seeks to implement the intervention, which includes patient-centered counseling and adherence supporter training, for both HIV-positive (for antiretroviral therapy, or ART) and HIV-negative (for pre-exposure prophylaxis, or PrEP) pregnant and breastfeeding women, thus providing a universal approach to support PMTCT programs holistically. The study will enroll pregnant women 18 years of age or older receiving antenatal care services at one of the designated study facilities. In Group 1, the study will enroll 100 HIV-positive women who started (or re-started, after a 6 months or longer treatment interruption) a first-line ART regimen within the past 30 days. In Group 2, the study will enroll 200 HIV-negative women willing to initiate and continue oral PrEP, in the form of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC), and who report factors that place them at elevated risk for HIV acquisition.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 300
- Documented pregnancy by urine pregnancy test or physical exam
- Documented positive HIV status
- Initiated on first-line antiretroviral therapy (ART) within the past 30 days, either for the first time or after treatment interruption of 6 months or longer (if previously started but stopped ART)
- Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- Ability and willingness to provide informed consent
- Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
- Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate
Eligibility criteria for enrollment in Group 2 (HIV-negative women):
Inclusion Criteria:
- Documented pregnancy by urine pregnancy test or physical exam
- Documented negative HIV status within the past three months
- Identified factor(s) for elevated risk for HIV acquisition, such as known positive or unknown partner HIV status; report of secondary sexual partners over the past 12 months; diagnosis of sexually transmitted infection over the past 12 months; use of post-exposure prophylaxis in the past 12 months; reported use of shared injection material or equipment; and/or unspecified concern about HIV acquisition during pregnancy and breastfeeding
- Willingness to initiate and continue HIV pre-exposure prophylaxis (PrEP) over the course of study follow-up
- Willingness to remain in the study site's catchment area over the course of study follow-up and to comply with visit schedule
- Ability and willingness to provide informed consent
Exclusion Criteria:
- Positive HIV test at time of screening
- Positive hepatitis B surface antigen test at time of screening
- Renal insufficiency, defined as creatinine clearance <90 mL/min, history of known renal parenchymal disease, or known single kidney at time of screening
- Risk for intimate partner violence or social harms as a result of participation, in the judgement of the study personnel
- Other conditions that, in the judgment of the study personnel, would make participation in the study inappropriate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2a: iNSC and Adherence supporter training iNSC and Adherence supporter training HIV-negative women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for PrEP. Group 1a: iNSC and Adherence supporter training iNSC and Adherence supporter training HIV-positive women randomly assigned to the intervention arm will receive a multi-component support strategy comprising iNSC and adherence supporter training for ART.
- Primary Outcome Measures
Name Time Method Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only) 6 months following study enrollment The primary outcome measure is retention in care with HIV viral suppression, defined as \<40 copies/mL.
Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only) 6 months following study enrollment The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.
- Secondary Outcome Measures
Name Time Method Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only) 6 months following study enrollment The secondary outcome measure is retention in care with self-reported ART adherence \>95% over the last 30 days. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized.
Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only) 6 months following study enrollment The secondary outcome measure is retention in care with HIV viral suppression, defined as \<1000 copies/mL.
Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only) 6 months following study enrollment The secondary outcome is retention in care with \>95% adherence to PrEP over the last 30 days by participant self-report. Participants were asked how many pills they missed in the prior 30 days and this was used to calculate percent adherence, which was then dichotomized.
Number of Participants Reporting Social Harms 6 months following study enrollment Newly reported social harms during study follow-up period. At each study visit, participants were asked if they had encountered any social harms related to study participation. These were documented and, where appropriate, referrals to social services were made.
Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session 6 months following study enrollment Extent to which Integrated Next Step Counseling (iNSC) was delivered as intended for each counseling session, obtained by audits of recorded counseling sessions. Counseling sessions were assessed according 50 evaluable actions. Each of these could be scored 0 (not done), 1 (partially done), and 2 (done well). These were aggregated into an overall score for fidelity, with an overall score range of 0-100. Higher scores represented greater counselor adherence to the iNSC framework.
Reported Level of Satisfaction by Participants for the Study Intervention 6 months following study enrollment Satisfaction with overall intervention. Participants were asked: "How satisfied would you say you are with the program overall (both the iNSC and the Adherence Supporter)?" The five possible answers are shown below.
Trial Locations
- Locations (1)
Bwaila District Hospital
🇲🇼Lilongwe, Malawi