N/A
N=43
Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
HIV · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT04846569 ↗Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Feasibility of the Intervention - Number of Counseling Sessions — 2.92; 1 sessions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transition Theory-based Intervention (Behavioral); Enhanced Standard of Care Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Brown University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of the Intervention - Number of Counseling Sessions |
2.92; 1 | — |
| PRIMARY Preliminary Efficacy - ART Adherence |
82.65; 82.73 | — |
| PRIMARY Preliminary Efficacy- Retention in HIV Services |
17; 15 | — |
| PRIMARY Preliminary Efficacy-viral Suppression |
11; 7 | — |
| SECONDARY Adherence Self-efficacy - Confidence in Taking Medications |
63.93; 69.55 | — |
| SECONDARY Acceptability/Utility of the Intervention |
11 | — |
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.
Eligibility Criteria
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the judgement of study personnel (including cognitive impairment or known psychotic disorder) Note: mothers will not be withdrawn from the study following foetal complications or death
Data sourced from ClinicalTrials.gov (NCT04846569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.