Postpartum Adherence Clubs for Antiretroviral Therapy

Hiv Clinical Trial

— PACART  

Official title:

Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200054
• Other study ID #: 195/2015
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: November 2020

Study information

• Verified date: May 2022
• Source: University of Cape Town
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 412
• Est. completion date: November 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv

Intervention

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.

Locations

Country	Name	City	State
South Africa	Gugulethu Community Health Centre	Cape Town	Western Cape

Sponsors (2)

Lead Sponsor	Collaborator
University of Cape Town	Medical Research Council

Country where clinical trial is conducted

South Africa, 

References & Publications (6)

Chi BH, Stringer JS, Moodley D. Antiretroviral drug regimens to prevent mother-to-child transmission of HIV: a review of scientific, program, and policy advances for sub-Saharan Africa. Curr HIV/AIDS Rep. 2013 Jun;10(2):124-33. doi: 10.1007/s11904-013-0154-z. Review. — View Citation

Coutsoudis A, Goga A, Desmond C, Barron P, Black V, Coovadia H. Is Option B+ the best choice? Lancet. 2013 Jan 26;381(9863):269-71. doi: 10.1016/S0140-6736(12)61807-8. — View Citation

Kaplan R, Orrell C, Zwane E, Bekker LG, Wood R. Loss to follow-up and mortality among pregnant women referred to a community clinic for antiretroviral treatment. AIDS. 2008 Aug 20;22(13):1679-81. doi: 10.1097/QAD.0b013e32830ebcee. — View Citation

Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernán MA, Boulle A. Effectiveness of patient adherence groups as a model of care for stable patients on antiretroviral therapy in Khayelitsha, Cape Town, South Africa. PLoS One. 2013;8(2):e56088. doi: 10.1371/journal.pone.0056088. Epub 2013 Feb 13. — View Citation

Nachega JB, Uthman OA, Anderson J, Peltzer K, Wampold S, Cotton MF, Mills EJ, Ho YS, Stringer JS, McIntyre JA, Mofenson LM. Adherence to antiretroviral therapy during and after pregnancy in low-income, middle-income, and high-income countries: a systematic review and meta-analysis. AIDS. 2012 Oct 23;26(16):2039-52. doi: 10.1097/QAD.0b013e328359590f. Review. — View Citation

Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral suppression	Time to viral load >1000 copies per ml	24 months
Secondary	Maternal retention in care	Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)	24 months
Secondary	Maternal death	Maternal deaths over the study period	24 months
Secondary	Maternal mental health	Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)	24 months
Secondary	Maternal health care service use	Use of health facilities including hospitalization	24 months
Secondary	Infant death	Infant deaths over the study period	24 months
Secondary	Infant health care service use	Use of health facilities including hospitalization	24 months
Secondary	Infant HIV testing	Uptake of routine infant HIV testing	24 months
Secondary	Infant HIV infection	Mother-to-child transmission of HIV	24 months
Secondary	Infant feeding	Breastfeeding practices	24 months
Secondary	Cost and cost-effectiveness	Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective	24 months
Secondary	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	24 months
Secondary	Viral suppression at other cutpoints (>400 copies/mL)	Time to VL >400 copies/mL	24 months
Secondary	Viral suppression at other cutpoints (>50 copies/mL)	Time to VL >50 copies/mL	24 months
Secondary	Virologic Failure	Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)	24 months
Secondary	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)	24 months
Secondary	Viral suppression at each study visit	VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)	24 months