Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
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|ClinicalTrials.gov Identifier: NCT04846569|
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : April 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|HIV Pregnancy Related||Behavioral: Transition Theory-based Intervention Behavioral: Enhanced Standard of Care Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa|
|Actual Study Start Date :||April 12, 2021|
|Estimated Primary Completion Date :||April 1, 2022|
|Estimated Study Completion Date :||July 31, 2022|
Experimental: Transition Theory-based Intervention
Participants in the intervention arm will receive the Transition Theory-based intervention consisting of 4 sessions with a community health worker (2 during pregnancy, 2 postpartum) to support their transition from pregnancy to postpartum.
Behavioral: Transition Theory-based Intervention
The behavioral intervention is a theoretically driven curriculum focused on supporting mothers from pregnancy through postpartum in order to promote sustained HIV treatment adherence. Sessions utilize motivational interviewing and consist of a range of topics including motherhood, preparing for baby, disclosure, HIV education, adherence, birth experiences, support systems, and living positively.
Active Comparator: Enhanced Standard of Care Control
Participants in the control arm will receive the standard of care plus one session with a community health worker.
Behavioral: Enhanced Standard of Care Control
In addition to standard of care, participants receive the first session of the Transition Theory-based Intervention curriculum which focuses on motherhood and preparation for baby but does not discuss the transition from pregnancy to postpartum or the postpartum period.
- Feasibility of the intervention - number of counseling sessions [ Time Frame: 3 months postpartum ]Feasibility will be assessed through the number of counseling sessions completed.
- Preliminary efficacy - VAS [ Time Frame: 6 months postpartum ]Preliminary efficacy will be assessed as the correlation between study arm and self-reported HIV adherence on the Visual-Analog Scale (self-report, 1 item scale from 0-100, 100 indicating perfect adherence in the past month) at 6 months postpartum.
- Preliminary efficacy- Retention in HIV services [ Time Frame: 6 months postpartum ]Preliminary efficacy will be assessed as the correlation between study arm and retention in HIV services at 6 months postpartum. Retention in HIV services is measured by clinic records. Retention at 6 months postpartum is measured as attended HIV clinic appointment in the past 3 months.
- Preliminary efficacy-viral suppression [ Time Frame: 6 months postpartum ]Preliminary efficacy will be assessed as the correlation between study arm and viral suppression at 6 months postpartum. Viral suppression will be measured by clinic records, with viral suppression defined as HIV viral load less than 200 copies/mL.
- Adherence self-efficacy - confidence in taking medications [ Time Frame: 6 months postpartum ]Adherence self-efficacy will be measured using the AACTG adherence self-efficacy scale, 15 items, using 5 point Likert scale ranging from not confident at all to very confident. Total scores range from 15-75, with higher scores indicating higher self-efficacy.
- Acceptability/Utility of the Intervention [ Time Frame: 6 months postpartum ]Acceptability of the Transition Theory-based intervention, assessed during in-depth interviews among participants in the intervention condition to gauge general feelings of acceptability and perceived usefulness of the intervention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846569
|Contact: Jennifer A Pellowski, PhDfirstname.lastname@example.org|
|Contact: Landon Myer, PhD||+27 (0)21 406 email@example.com|
|Gugulethu Community Health Centre||Recruiting|
|Cape Town, South Africa|
|Contact: Nokwazi Tsawe +27 (0)73 977-9886 firstname.lastname@example.org|
|Principal Investigator:||Jennifer A Pellowski, PhD||Brown University|