Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04846569
Recruitment Status : Recruiting
First Posted : April 15, 2021
Last Update Posted : April 23, 2021
Sponsor:
Collaborators:
University of Cape Town
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Brown University

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.

Condition or disease Intervention/treatment Phase
HIV Pregnancy Related Behavioral: Transition Theory-based Intervention Behavioral: Enhanced Standard of Care Control Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adherence to HIV Treatment Postpartum: The Implications of Transitions Among Women Living With HIV in South Africa
Actual Study Start Date : April 12, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
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.

Active Comparator: Enhanced Standard of Care Control
Participants in the control arm will receive the standard of care plus one session with a community health worker.
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.




Primary Outcome Measures :
  1. Feasibility of the intervention - number of counseling sessions [ Time Frame: 3 months postpartum ]
    Feasibility will be assessed through the number of counseling sessions completed.

  2. Preliminary efficacy - VAS [ Time Frame: 6 months postpartum ]
    Preliminary efficacy will be assessed as the correlation between study arm and self-reported HIV adherence on the Visual-Analog Scale (self-report, 1 item scale from 0-100, 100 indicating perfect adherence in the past month) at 6 months postpartum.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Adherence self-efficacy - confidence in taking medications [ Time Frame: 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.

  2. Acceptability/Utility of the Intervention [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   We will enroll only pregnant women.
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04846569


Contacts
Layout table for location contacts
Contact: Jennifer A Pellowski, PhD 8609082406 jennifer_pellowski@brown.edu
Contact: Landon Myer, PhD +27 (0)21 406 6661 landon.myer@uct.ac.za

Locations
Layout table for location information
South Africa
Gugulethu Community Health Centre Recruiting
Cape Town, South Africa
Contact: Nokwazi Tsawe    +27 (0)73 977-9886    lizizikazi@gmail.com   
Sponsors and Collaborators
Brown University
University of Cape Town
National Institute of Mental Health (NIMH)
Investigators
Layout table for investigator information
Principal Investigator: Jennifer A Pellowski, PhD Brown University
Layout table for additonal information
Responsible Party: Brown University
ClinicalTrials.gov Identifier: NCT04846569    
Other Study ID Numbers: 1707001841
K01MH112443 ( U.S. NIH Grant/Contract )
First Posted: April 15, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified datasets will be made available by request, subject to agreement to Access Criteria, see below
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After primary data has been published (anticipated September 2022), by request
Access Criteria: (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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brown University:
HIV
Pregnancy
Postpartum
South Africa