Postpartum Adherence Clubs for Antiretroviral Therapy
- Conditions
- Hiv
- Interventions
- Other: Adherence Clubs
- Registration Number
- NCT03200054
- Lead Sponsor
- University of Cape Town
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 412
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Adherence Club Care Adherence Clubs 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.
- Primary Outcome Measures
Name Time Method Viral suppression 24 months Time to viral load \>1000 copies per ml
- Secondary Outcome Measures
Name Time Method Maternal retention in care 24 months Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
Maternal death 24 months Maternal deaths over the study period
Maternal health care service use 24 months Use of health facilities including hospitalization
Cost and cost-effectiveness 24 months Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
Maternal mental health 24 months Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
Infant HIV testing 24 months Uptake of routine infant HIV testing
Infant health care service use 24 months Use of health facilities including hospitalization
Infant HIV infection 24 months Mother-to-child transmission of HIV
Infant feeding 24 months Breastfeeding practices
Viral suppression at other cutpoints (>400 copies/mL) 24 months Time to VL \>400 copies/mL
Acceptability of each ART service 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 (>50 copies/mL) 24 months Time to VL \>50 copies/mL
Virologic Failure 24 months Time to clinical definition of virologic failure (two consecutive VLs \>1000 copies/mL)
Combined retention/VL outcome 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 24 months VL \>50 copies/mL or \>1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
Infant death 24 months Infant deaths over the study period
Trial Locations
- Locations (1)
Gugulethu Community Health Centre
🇿🇦Cape Town, Western Cape, South Africa