N/A
Completed N=300
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
HIV-1 Infection · Antenatal Care
Source: ClinicalTrials.gov NCT04330989 ↗
Enrolled (actual)
300
Serious AEs
7.7%
Results posted
Jan 2023
Primary outcomePrimary: Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only) — 35; 30 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only) |
35; 30 | — |
| PRIMARY Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only) |
22; 26 | — |
| SECONDARY Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session |
89.3; 80.4 | — |
| SECONDARY Reported Level of Satisfaction by Participants for the Study Intervention |
42; 89; 1; 2; 0; 0 | — |
| SECONDARY Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only) |
37; 35 | — |
| SECONDARY Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only) |
37; 32 | — |
| SECONDARY Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only) |
45; 43 | — |
| SECONDARY Number of Participants Reporting Social Harms |
0; 0; 1; 2 | — |
Eligibility Criteria
Eligibility criteria for enrollment in Group 1 (HIV-positive women):
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04330989). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.