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| ID | Type | Description | Link |
|---|---|---|---|
| K01MH112443 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Cape Town | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transition Theory-based Intervention | Experimental | 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. |
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| Enhanced Standard of Care Control | Active Comparator | Participants in the control arm will receive the standard of care plus one session with a community health worker. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transition Theory-based Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of the Intervention - Number of Counseling Sessions | Feasibility will be assessed through the number of counseling sessions completed. | 3 months postpartum |
| 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. | 6 months postpartum |
| 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. | 6 months postpartum |
| 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. | 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months postpartum |
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Inclusion Criteria:
Exclusion Criteria:
We will enroll only pregnant women.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer A Pellowski, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gugulethu Community Health Centre | Cape Town | South Africa |
De-identified datasets will be made available by request, subject to agreement to Access Criteria, see below
After primary data has been published (anticipated September 2022), by request
(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.
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Participants completed consent on a separate day from baseline and randomization.
Recruitment occurred between April 2021 and March 2022 at the Gugulethu Midwife Obstetrics Unit (MOU), Cape Town, South Africa.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of the Intervention - Number of Counseling Sessions | Feasibility will be assessed through the number of counseling sessions completed. | 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 | Posted | Mean | Standard Deviation | sessions | 3 months postpartum |
|
9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Pellowski | Brown University | 4018635453 | jennifer_pellowski@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 5, 2021 | Dec 1, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2021 | Dec 12, 2023 | ICF_001.pdf |
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| Enhanced Standard of Care Control | Behavioral | 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. |
|
| 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. |
| 6 months postpartum |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Baseline self-report ART Adherence | self-reported adherence using Wilson's 3 item adherence scale. Scores are transformed to follow a scale from 0-100 in which 100 is perfect adherence | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
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| 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. | There was substantial LTFU for the 6 month postpartum timepoints. Analyses are conducted with all participants for whom these assessments were collected. | Posted | Mean | Standard Deviation | score on a scale | 6 months postpartum |
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| 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. | Posted | Count of Participants | Participants | 6 months postpartum |
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| 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. | Posted | Count of Participants | Participants | 6 months postpartum |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 6 months postpartum |
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| 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. | 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 | Posted | Count of Participants | Participants | 6 months postpartum |
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| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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