- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04330989
An Integrated Strategy to Support Antiretroviral Therapy and Pre-exposure Prophylaxis Adherence for HIV Prevention in Pregnant and Breastfeeding Women
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Lilongwe, Malawi
- Bwaila District Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group 1a: 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.
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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. |
No Intervention: Group 1b: Standard of Care
HIV-positive participants randomly assigned to the control arm will antiretroviral educational material about HIV prevention and treatment (as appropriate to this arm).
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Experimental: Group 2a: 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.
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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. |
No Intervention: Group 2b: Standard of Care
HIV-negative participants randomly assigned to the control arm will receive educational material about HIV prevention and treatment (as appropriate to this arm).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Retained in Care With HIV Viral Suppression <40 Copies/mL (Groups 1a and 1b Only)
Time Frame: 6 months following study enrollment
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The primary outcome measure is retention in care with HIV viral suppression, defined as <40 copies/mL.
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6 months following study enrollment
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Number of Participants Retained in Care With Functional Adherence to PrEP (Groups 2a and 2b Only)
Time Frame: 6 months following study enrollment
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The primary outcome is retention in care with functional adherence to PrEP as measured categorically according to plasma and intracellular tenofovir drug concentrations.
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6 months following study enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fidelity Score Indicating How Counselors Correctly Delivered Integrated Next Step Counseling by Session
Time Frame: 6 months following study enrollment
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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.
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6 months following study enrollment
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Reported Level of Satisfaction by Participants for the Study Intervention
Time Frame: 6 months following study enrollment
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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.
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6 months following study enrollment
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Number of Participants Retained in Care With HIV Viral Suppression <1000 Copies/mL (Groups 1a and 1b Only)
Time Frame: 6 months following study enrollment
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The secondary outcome measure is retention in care with HIV viral suppression, defined as <1000 copies/mL.
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6 months following study enrollment
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Number of Participants Retained in Care With ART Adherence >95% Over the Last 30 Days (Groups 1a and 1b Only)
Time Frame: 6 months following study enrollment
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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.
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6 months following study enrollment
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Number of Participants Retained in Care With >95% Adherence to PrEP Over Last 30 Days (Groups 2a and 2b Only)
Time Frame: 6 months following study enrollment
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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.
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6 months following study enrollment
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Number of Participants Reporting Social Harms
Time Frame: 3 months following study enrollment
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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.
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3 months following study enrollment
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Number of Participants Reporting Social Harms
Time Frame: 6 months following study enrollment
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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.
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6 months following study enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: Benjamin Chi, MD, MSc, University of North Carolina, Chapel Hill
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 19-1060
- R01AI131060 (NIH)
- UNCPMZ 41901 (Other Identifier: UNC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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