HIV, Pregnancy Related
Conditions
Keywords
HIV, Pregnancy, Postpartum, South Africa
Brief 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.
Interventions
BEHAVIORALTransition 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.
BEHAVIORALEnhanced 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.
Sponsors
University of Cape Town
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 18 years of age or older 2. HIV positive status (based on clinic records) 3. Confirmed pregnant (based on clinic records) and estimated to be 23-34 weeks gestation (clinic records or self-report) 4. Currently prescribed ART 5. Planning on remaining a resident of Cape Town for at least 6 months postpartum 6. Ability to speak isiXhosa or English 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of the Intervention - Number of Counseling Sessions | 3 months postpartum | Feasibility will be assessed through the number of counseling sessions completed. |
| Preliminary Efficacy - ART Adherence | 6 months postpartum | Preliminary efficacy will be assessed as the correlation between study arm and self-reported HIV adherence on the 3 item Wilson ART adherence scale (self-report, 3 item scale recoded as 0-100, 100 indicating perfect adherence in the past month) at 6 months postpartum. |
| Preliminary Efficacy- Retention in HIV Services | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Self-efficacy - Confidence in Taking Medications | 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 | 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. |
Countries
South Africa
Participant flow
Recruitment details
Recruitment occurred between April 2021 and March 2022 at the Gugulethu Midwife Obstetrics Unit (MOU), Cape Town, South Africa.
Pre-assignment details
Participants completed consent on a separate day from baseline and randomization.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| 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. | 20 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Transition Theory-based Intervention | Enhanced Standard of Care Control | Total |
|---|---|---|---|
| Age, Continuous | 33 Years STANDARD_DEVIATION 5.62 | 32 Years STANDARD_DEVIATION 6.13 | 33 Years STANDARD_DEVIATION 5.82 |
| Baseline self-report ART Adherence | 80.72 units on a scale STANDARD_DEVIATION 2.41 | 76.84 units on a scale STANDARD_DEVIATION 2.09 | 78.92 units on a scale STANDARD_DEVIATION 1.62 |
| Race/Ethnicity, Customized Black South African | 23 Participants | 20 Participants | 43 Participants |
| Region of Enrollment South Africa | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Female | 23 Participants | 20 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 23 | 0 / 20 |
| other Total, other adverse events | 0 / 23 | 0 / 20 |
| serious Total, serious adverse events | 0 / 23 | 0 / 20 |
Outcome results
Primary
Feasibility of the Intervention - Number of Counseling Sessions
Feasibility will be assessed through the number of counseling sessions completed.
Time frame: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition Theory-based Intervention | Feasibility of the Intervention - Number of Counseling Sessions | 2.92 sessions | Standard Deviation 1.28 |
| Enhanced Standard of Care Control | Feasibility of the Intervention - Number of Counseling Sessions | 1 sessions | Standard Deviation 0 |
Primary
Preliminary Efficacy - ART Adherence
Preliminary efficacy will be assessed as the correlation between study arm and self-reported HIV adherence on the 3 item Wilson ART adherence scale (self-report, 3 item scale recoded as 0-100, 100 indicating perfect adherence in the past month) at 6 months postpartum.
Time frame: 6 months postpartum
Population: There was substantial LTFU for the 6 month postpartum timepoints. Analyses are conducted with all participants for whom these assessments were collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition Theory-based Intervention | Preliminary Efficacy - ART Adherence | 82.65 score on a scale | Standard Deviation 11.15 |
| Enhanced Standard of Care Control | Preliminary Efficacy - ART Adherence | 82.73 score on a scale | Standard Deviation 8.82 |
95% CI: [-0.38, 0.39]
Primary
Preliminary Efficacy- Retention in HIV Services
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.
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transition Theory-based Intervention | Preliminary Efficacy- Retention in HIV Services | 17 Participants |
| Enhanced Standard of Care Control | Preliminary Efficacy- Retention in HIV Services | 15 Participants |
95% CI: [-0.78, 0.47]
Primary
Preliminary Efficacy-viral Suppression
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.
Time frame: 6 months postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transition Theory-based Intervention | Preliminary Efficacy-viral Suppression | 11 Participants |
| Enhanced Standard of Care Control | Preliminary Efficacy-viral Suppression | 7 Participants |
Comparison: All participants who we were able to obtain records for were virally suppressed thus an effect size was unable to be calculated.
Secondary
Acceptability/Utility of the Intervention
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.
Time frame: 6 months postpartum
Population: 11 participants randomized to the intervention arm completed qualitative interviews following the 6 month follow-up assessment and are used in the qualitative analysis. Count represents number of participants who reported positively about the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Transition Theory-based Intervention | Acceptability/Utility of the Intervention | 11 Participants |
Secondary
Adherence Self-efficacy - Confidence in Taking Medications
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.
Time frame: 6 months postpartum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transition Theory-based Intervention | Adherence Self-efficacy - Confidence in Taking Medications | 63.93 units on a scale | Standard Deviation 4.95 |
| Enhanced Standard of Care Control | Adherence Self-efficacy - Confidence in Taking Medications | 69.55 units on a scale | Standard Deviation 0.45 |
95% CI: [-0.2, 0.53]