Trial Outcomes & Findings for Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa (NCT NCT04846569)

Results Overview

Feasibility will be assessed through the number of counseling sessions completed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

62 participants

Primary outcome timeframe

3 months postpartum

Results posted on

2024-02-28

Participant Flow

Recruitment occurred between April 2021 and March 2022 at the Gugulethu Midwife Obstetrics Unit (MOU), Cape Town, South Africa.

Participants completed consent on a separate day from baseline and randomization.

Participant milestones

Participant milestones
Measure	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. 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.	Enhanced Standard of Care Control Participants in the control arm will receive the standard of care plus one session with a community health worker. 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.
Overall Study STARTED	23	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	Enhanced Standard of Care Control Participants in the control arm will receive the standard of care plus one session with a community health worker. 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.
Overall Study Withdrawal by Subject	3	1

Baseline Characteristics

Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transition Theory-based Intervention n=23 Participants 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. 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.	Enhanced Standard of Care Control n=20 Participants Participants in the control arm will receive the standard of care plus one session with a community health worker. 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.	Total n=43 Participants Total of all reporting groups
Age, Continuous	33 Years STANDARD_DEVIATION 5.62 • n=5 Participants	32 Years STANDARD_DEVIATION 6.13 • n=7 Participants	33 Years STANDARD_DEVIATION 5.82 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black South African	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Region of Enrollment South Africa	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Baseline self-report ART Adherence	80.72 units on a scale STANDARD_DEVIATION 2.41 • n=5 Participants	76.84 units on a scale STANDARD_DEVIATION 2.09 • n=7 Participants	78.92 units on a scale STANDARD_DEVIATION 1.62 • n=5 Participants

PRIMARY outcome

Timeframe: 3 months postpartum

Population: Transition Theory-based intervention participants received 4 counseling sessions compared to 1 session for those in the enhanced standard of care control condition; means are reported based on these denominators and should not be compared by condition

Feasibility will be assessed through the number of counseling sessions completed.