An interventional study of Adherence Clubs in Hiv, sponsored by University of Cape Town. Completed at 1 site in South Africa. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of Cape Town · Not applicable, Interventional, and Health services research
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.
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.
2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.
This study's enrollment of 412 is above the median of 104 across 1,590 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →University of Cape Town is the lead sponsor of 116 studies on the registry; 14 are open to participants now.
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Exclusion Criteria:
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.
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.
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.
Viral suppression
Time to viral load \>1000 copies per ml
Time frame: 24 months
Maternal retention in care
Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
Time frame: 24 months
Maternal death
Maternal deaths over the study period
Time frame: 24 months
Maternal mental health
Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
Time frame: 24 months
Maternal health care service use
Use of health facilities including hospitalization
Time frame: 24 months
Infant death
Infant deaths over the study period
Time frame: 24 months
Infant health care service use
Use of health facilities including hospitalization
Time frame: 24 months
Infant HIV testing
Uptake of routine infant HIV testing
Time frame: 24 months
Infant HIV infection
Mother-to-child transmission of HIV
Time frame: 24 months
Infant feeding
Breastfeeding practices
Time frame: 24 months
Cost and cost-effectiveness
Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
Time frame: 24 months
Acceptability of each ART service
Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
Time frame: 24 months
Viral suppression at other cutpoints (>400 copies/mL)
Time to VL \>400 copies/mL
Time frame: 24 months
Viral suppression at other cutpoints (>50 copies/mL)
Time to VL \>50 copies/mL
Time frame: 24 months
Virologic Failure
Time to clinical definition of virologic failure (two consecutive VLs \>1000 copies/mL)
Time frame: 24 months
Combined retention/VL outcome
Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL \>50 or 1000 copies/mL)
Time frame: 24 months
Viral suppression at each study visit
VL \>50 copies/mL or \>1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
Time frame: 24 months
Plan to share: No
Ran from Jan 2016 to primary completion in Jan 2020, 48 months.
Of 497 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's 48 months is above that.
Counting every sponsor, half of 500 studies reached it within 31 months; a quarter within 18 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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