HIVNCT04846569
Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
A study testing Transition Theory-based Intervention in people with HIV and Pregnancy Related, run by Brown University at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Pregnancy Related
- What is being tested?
- Transition Theory-based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Apr 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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the judgement of study personnel (including cognitive impairment or known psychotic disorder) Note: mothers will not be withdrawn from the study following foetal complications or death
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- HIV, Pregnancy Related
- Being tested
- Transition Theory-based Intervention, Enhanced Standard of Care Control
- Keywords
- HIV, Pregnancy, Postpartum, South Africa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transition Theory-based InterventionBehavioural
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.
Enhanced Standard of Care ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transition Theory-based Intervention |
| 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. Receives: Behavioral: Enhanced Standard of Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the Intervention - Number of Counseling Sessions
Feasibility will be assessed through the number of counseling sessions completed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months postpartum
Secondary outcomes (2)
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.
Measured: 6 months postpartum
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.
Measured: 6 months postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start12 Apr 2021
- Primary completion30 Dec 2022
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Jennifer A Pellowski, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846569
- Sponsor's protocol ID
- 1707001841
- Other IDs
- K01MH112443
- Status last verified
- Feb 2024
- First submitted
- 8 Apr 2021
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified datasets will be made available by request, subject to agreement to Access Criteria, see below
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
- ClinicalTrials.gov ID
- NCT04846569
- Acronym / sponsor ID
- 1707001841
- Conditions
- HIV, Pregnancy Related
- Keywords
- HIV, Pregnancy, Postpartum, South Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- University of Cape Town, National Institute of Mental Health (NIMH)
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 15 Apr 2021 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transition Theory-based Intervention | Experimental | Behavioral: Transition Theory-based InterventionParticipants 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. |
| Enhanced Standard of Care Control | Active comparator | Behavioral: Enhanced Standard of Care ControlParticipants in the control arm will receive the standard of care plus one session with a community health worker. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transition Theory-based InterventionThe 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. | Behavioural | Transition Theory-based Intervention |
| Enhanced Standard of Care ControlIn 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. | Behavioural | Enhanced Standard of Care Control |
Primary outcome
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 - ART Adherence
Time frame: 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
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.
2 secondary outcomes
Adherence Self-efficacy - Confidence in Taking Medications
Time frame: 6 months postpartum
Acceptability/Utility of the Intervention
Time frame: 6 months postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified datasets will be made available by request, subject to agreement to Access Criteria, see below
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer A Pellowski, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transition Theory-based Intervention in people with HIV and Pregnancy Related, run by Brown University at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the Intervention - Number of Counseling Sessions (time frame: 3 months postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.