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Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200054
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
Medical Research Council
Information provided by (Responsible Party):
Professor Landon Myer, University of Cape Town

Tracking Information
First Submitted Date  ICMJE March 21, 2017
First Posted Date  ICMJE June 27, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
Viral suppression [ Time Frame: 24 months ]
Time to viral load >1000 copies per ml
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
Viral suppression [ Time Frame: 24 months ]
Viral load <50 copies per ml up to 24 month visit
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2019)
  • Maternal retention in care [ Time Frame: 24 months ]
    Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
  • Maternal death [ Time Frame: 24 months ]
    Maternal deaths over the study period
  • Maternal mental health [ Time Frame: 24 months ]
    Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
  • Maternal health care service use [ Time Frame: 24 months ]
    Use of health facilities including hospitalization
  • Infant death [ Time Frame: 24 months ]
    Infant deaths over the study period
  • Infant health care service use [ Time Frame: 24 months ]
    Use of health facilities including hospitalization
  • Infant HIV testing [ Time Frame: 24 months ]
    Uptake of routine infant HIV testing
  • Infant HIV infection [ Time Frame: 24 months ]
    Mother-to-child transmission of HIV
  • Infant feeding [ Time Frame: 24 months ]
    Breastfeeding practices
  • Cost and cost-effectiveness [ Time Frame: 24 months ]
    Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
  • Acceptability of each ART service [ Time Frame: 24 months ]
    Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
  • Viral suppression at other cutpoints (>400 copies/mL) [ Time Frame: 24 months ]
    Time to VL >400 copies/mL
  • Viral suppression at other cutpoints (>50 copies/mL) [ Time Frame: 24 months ]
    Time to VL >50 copies/mL
  • Virologic Failure [ Time Frame: 24 months ]
    Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
  • Combined retention/VL outcome [ Time Frame: 24 months ]
    Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
  • Viral suppression at each study visit [ Time Frame: 24 months ]
    VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2017)
  • Maternal retention in care [ Time Frame: 24 months ]
    Missed routinely scheduled clinical care visits
  • Maternal death [ Time Frame: 24 months ]
    Maternal deaths over the study period
  • Maternal mental health [ Time Frame: 24 months ]
    Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
  • Maternal health care service use [ Time Frame: 24 months ]
    Use of health facilities including hospitalization
  • Infant death [ Time Frame: 24 months ]
    Infant deaths over the study period
  • Infant health care service use [ Time Frame: 24 months ]
    Use of health facilities including hospitalization
  • Infant HIV testing [ Time Frame: 24 months ]
    Uptake of routine infant HIV testing
  • Infant HIV infection [ Time Frame: 24 months ]
    Mother-to-child transmission of HIV
  • Infant feeding [ Time Frame: 24 months ]
    Breastfeeding practices
  • Cost and cost-effectiveness [ Time Frame: 24 months ]
    Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
  • Acceptability of each ART service [ Time Frame: 24 months ]
    Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postpartum Adherence Clubs for Antiretroviral Therapy
Official Title  ICMJE Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
Brief Summary South Africa is implementing the policy of universal initiation of lifelong antiretroviral therapy (ART) in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+"). There is a recognised need for innovative models of service delivery to support adherence and retention in care in this group, particularly during the postpartum period. The investigators are conducting a pragmatic randomised control trial to compare virological outcomes 24 months postpartum in two models of service delivery for provision of HIV care and treatment services postpartum in women who initiated ART during pregnancy: local adult ART clinics and community-based adherence clubs.
Detailed Description South Africa is implementing the policy of universal initiation of lifelong ART in all HIV-infected pregnant women regardless of CD4 cell count or disease stage ("Option B+") and given the high antenatal HIV seroprevalence, HIV-infected pregnant women represent the largest group of patients initiating ART in primary care facilities. However, there are few well developed models of service delivery to support implementation. There are particular concerns regarding the postpartum period, with multiple studies indicating high levels of non-retention in care and/or inadequate adherence to treatment postnatally. Adherence Clubs (ACs) are an innovative but untested model of care based on chronic disease management strategies that emphasize social support, adherence to treatment and retention in care, rather than intensive clinical management, as the most important determinant of long-term health outcomes in stable patients in chronic care. ACs have preliminarily been shown to to result in virologic outcomes that are similar to routine clinic services in patients stable on ART. The investigators are conducting a pragmatic, randomised controlled trial to evaluate two different strategies for delivering HIV care and treatment services during the postpartum period to HIV-infected women who initiated ART during pregnancy. Participants will be allocated to receive ART care at either local adult ART clinics, following the current standard of care, or the community-based adherence club system.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Condition  ICMJE Hiv
Intervention  ICMJE Other: Adherence Clubs
Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC). AC visits occur 2-4 monthly at a community hall near the CHC. At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART. Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse. A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit. Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse.
Study Arms  ICMJE
  • No Intervention: Clinic-based Care
    Clinic-based care is the current standard of care and is defined as referral of women on antiretroviral therapy (ART) to general primary care adult ART services.
  • Experimental: Adherence Club Care
    Adherence club care involves referral of women on ART to community-based ART services in the form of adherence clubs, which are led by community health workers and supported by ART clinic nurses.
    Intervention: Other: Adherence Clubs
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 8, 2018)
412
Original Estimated Enrollment  ICMJE
 (submitted: June 23, 2017)
388
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented HIV infection with ART initiation during the preceding antenatal period
  • Within 70 days post-delivery
  • Viral suppression documented in pregnancy with the most recent viral load <400 copies/mL within the last 3 months
  • Willingness to be randomised and return for study measurement visits
  • Able and willing to attend service visits at either a local ART treatment centre or the adherence club at Ikhwezi centre
  • Able to provide informed consent for research

Exclusion Criteria:

  • Intention to relocate out of Cape Town permanently during the study period
  • Any medical, psychiatric or social condition which in the opinion of the investigators would affect the ability to consent and/or participate in the study including: refusal to take ART/antiretrovirals (ARVs) and/or denial of HIV status
  • Loss of pregnancy/neonate at the time of eligibility determination
  • Current co-morbidity requiring additional health care attention, including opportunistic infections such as tuberculosis (TB) disease or any chronic condition or other condition that is not controlled or stable
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03200054
Other Study ID Numbers  ICMJE 195/2015
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Professor Landon Myer, University of Cape Town
Study Sponsor  ICMJE University of Cape Town
Collaborators  ICMJE Medical Research Council
Investigators  ICMJE
Principal Investigator: Landon Myer, MBChB PhD University of Cape Town
PRS Account University of Cape Town
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP