Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04846569 |
Recruitment Status :
Recruiting
First Posted : April 15, 2021
Last Update Posted : April 23, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |

Arm | Intervention/treatment |
---|---|
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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | We will enroll only pregnant women. |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18 years of age or older
- HIV positive status (based on clinic records)
- Confirmed pregnant (based on clinic records) and estimated to be 23-34 weeks gestation (clinic records or self-report)
- Currently prescribed ART
- Planning on remaining a resident of Cape Town for at least 6 months postpartum
- Ability to speak isiXhosa or English
- Able to provide informed consent
Exclusion Criteria:
- Failure to meet any of the inclusion criteria
- Significant pre-existing psychiatric comorbidity at enrolment that may impact ability to consent according to the judgement of study personnel (including cognitive impairment or known psychotic disorder) Note: mothers will not be withdrawn from the study following foetal complications or death

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, PhD | 8609082406 | jennifer_pellowski@brown.edu | |
Contact: Landon Myer, PhD | +27 (0)21 406 6661 | landon.myer@uct.ac.za |
South Africa | |
Gugulethu Community Health Centre | Recruiting |
Cape Town, South Africa | |
Contact: Nokwazi Tsawe +27 (0)73 977-9886 lizizikazi@gmail.com |
Principal Investigator: | Jennifer A Pellowski, PhD | Brown University |
Responsible Party: | Brown University |
ClinicalTrials.gov Identifier: | NCT04846569 |
Other Study ID Numbers: |
1707001841 K01MH112443 ( U.S. NIH Grant/Contract ) |
First Posted: | April 15, 2021 Key Record Dates |
Last Update Posted: | April 23, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | De-identified datasets will be made available by request, subject to agreement to Access Criteria, see below |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) |
Time Frame: | After primary data has been published (anticipated September 2022), by request |
Access Criteria: | (1) a commitment to use the data only for research purposes and not to identify any individual participant; (2) a commitment to secure the data using appropriate computer technology and established security measures; (3) a plan for the dissemination of results; (4) appropriate authorship and recognition of all partners; and (5) a commitment to destroy or return the data after analyses are completed. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
HIV Pregnancy Postpartum South Africa |