Trials / Completed
CompletedNCT04846569
Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Brown University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
Despite high levels of adherence motivation during pregnancy, HIV treatment adherence and engagement in care is difficult for women in the postpartum period. Supporting women during the transition from pregnancy to postpartum is imperative to sustaining HIV treatment adherence during this period. The investigators are conducting a small scale pilot study of a behavioral Transition Theory-based intervention to support ART adherence and engagement in ART services among pregnant and postpartum women living with HIV.
Detailed description
Prevention of mother-to-child transmission (PMTCT) efforts have reduced the rates of vertical transmission to 2.7%, however, optimal antiretroviral therapy (ART) adherence remains a difficult goal to reach, particularly postpartum. Longitudinal qualitative research reveals a variety of facilitators and barriers to the transition from pregnancy to postpartum including employment/financial concerns, logistical concerns around childcare and breastfeeding, worries about vertical transmission and difficulties bonding. This intervention draws on the growing cadre of community health workers within the South African health care system and Transition Theory to develop a behavioral intervention to support women living with HIV through the transition from pregnancy to postpartum. The investigators are conducting a small scale pilot study to compare the impact of a Transition Theory-based intervention to enhanced standard of care on self-reported ART adherence and engagement in ART services among pregnant and postpartum women living with HIV.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2021-04-12
- Primary completion
- 2022-12-30
- Completion
- 2023-09-30
- First posted
- 2021-04-15
- Last updated
- 2024-02-28
- Results posted
- 2024-02-28
Locations
1 site across 1 country: South Africa
Source: ClinicalTrials.gov record NCT04846569. Inclusion in this directory is not an endorsement.