Postpartum Adherence Clubs for Antiretroviral Therapy (PACART)
17 maj 2022 uppdaterad av: Professor Landon Myer, University of Cape Town
Postpartum Adherence Clubs for Antiretroviral Therapy: a Randomised Controlled Trial
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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
412
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Western Cape
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Cape Town, Western Cape, Sydafrika, 7750
- Gugulethu Community Health Centre
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Inget ingripande: 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.
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Experimentell: 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.
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Viral suppression
Tidsram: 24 months
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Time to viral load >1000 copies per ml
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24 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Maternal retention in care
Tidsram: 24 months
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Missed routinely scheduled clinical care visits (missed visit and no visit within 3 months of scheduled clinic visit)
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24 months
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Maternal death
Tidsram: 24 months
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Maternal deaths over the study period
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24 months
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Maternal mental health
Tidsram: 24 months
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Mental health as assessed via brief screening tools (Edinburgh Postnatal Depression Scale)
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24 months
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Maternal health care service use
Tidsram: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant death
Tidsram: 24 months
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Infant deaths over the study period
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24 months
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Infant health care service use
Tidsram: 24 months
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Use of health facilities including hospitalization
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24 months
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Infant HIV testing
Tidsram: 24 months
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Uptake of routine infant HIV testing
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24 months
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Infant HIV infection
Tidsram: 24 months
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Mother-to-child transmission of HIV
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24 months
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Infant feeding
Tidsram: 24 months
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Breastfeeding practices
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24 months
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Cost and cost-effectiveness
Tidsram: 24 months
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Cost-effectiveness of each strategy will be analysed from both the patient and health systems perspective
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24 months
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Acceptability of each ART service
Tidsram: 24 months
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Acceptability of each service will be assessed using the patient-provider interview schedule, and qualitative interviews will be done on a subset of participants
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24 months
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Viral suppression at other cutpoints (>400 copies/mL)
Tidsram: 24 months
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Time to VL >400 copies/mL
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24 months
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Viral suppression at other cutpoints (>50 copies/mL)
Tidsram: 24 months
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Time to VL >50 copies/mL
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24 months
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Virologic Failure
Tidsram: 24 months
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Time to clinical definition of virologic failure (two consecutive VLs >1000 copies/mL)
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24 months
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Combined retention/VL outcome
Tidsram: 24 months
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Composite endpoint of retention in care and viral suppression (not retained in care OR retained but VL >50 or 1000 copies/mL)
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24 months
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Viral suppression at each study visit
Tidsram: 24 months
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VL >50 copies/mL or >1000 copies/mL at each study visit (3, 6, 12, 18, 24 months)
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24 months
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Landon Myer, MBChB PhD, University of Cape Town
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Luque-Fernandez MA, Van Cutsem G, Goemaere E, Hilderbrand K, Schomaker M, Mantangana N, Mathee S, Dubula V, Ford N, Hernan 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.
- 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.
- 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.
- 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. No abstract available.
- 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.
- Provincial Government of the Western Cape. PMTCT Clinical Guidelines Update, May 2013. Cape Town: PGWC; 2013.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 januari 2016
Primärt slutförande (Faktisk)
1 januari 2020
Avslutad studie (Faktisk)
1 november 2020
Studieregistreringsdatum
Först inskickad
21 mars 2017
Först inskickad som uppfyllde QC-kriterierna
23 juni 2017
Första postat (Faktisk)
27 juni 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 maj 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
17 maj 2022
Senast verifierad
1 maj 2022
Mer information
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Nyckelord
Andra studie-ID-nummer
- 195/2015
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