Promoting Uptake and Retention of Option B+ in Malawi (PURE)

Improving Uptake and Retention in PMTCT Services Through Novel Approaches in Family Supported Care and in Community Peer Outreach Support in Malawi

The purpose of this study is to determine if enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.

Study Overview

• Status: Unknown
• Conditions: HIV
• Intervention / Treatment: Other: Facility-based Peer Support; Other: Community based peer support

Detailed Description

The Malawi Ministry of Health (MoH) has embarked on a novel and ambitious programme to prevent mother to child transmission of HIV (PMTCT) known as "Option B Plus". This programme takes a public health approach to promote maternal health and eliminate paediatric HIV infections through a "test and treat" model, offering all HIV-infected pregnant and breastfeeding women lifelong ART regardless of CD4 count or clinical stage. The overall goal is to improve ART uptake and retention, and thus outcomes, of HIV-infected pregnant women and their infants in the continuum of ART services.

Although the Option B Plus strategy offers an attractive rapid ART scale-up alternative to the WHO PMTCT recommendations and has the potential to profoundly impact maternal and infant outcomes, it has not been implemented in any programme setting. Operational challenges throughout the cascade of PMTCT services may affect the uptake and adherence to highly active ART treatment (HAART) by pregnant women, the follow-up of HIV-exposed infants and the long-term retention of this patient population. Several issues identified at the national level are potential threats to the successful implementation and scale up of Option B plus: a) potential suboptimal uptake of HAART by asymptomatic pregnant women due to low treatment literacy and stigma; b) low adherence to HAART and poor follow-up of HIV exposed infants; and c) lack of psycho-social support for long term retention in this relatively asymptomatic patient population (Schouten et al. 2011).

The aim of the overall project (4 years) is to evaluate facility-based and community-based support models to strengthen uptake and retention of mothers and families in PMTCT care in Malawi. Our hypothesis is that enhanced support for women and their families within facilities and/or through community outreach will result in improved retention in the continuum of PMTCT care.

We will conduct a cluster randomized clinical trial evaluating three support models for the implementation of the Option B+ program. Each of the 21 clinics will be randomized to one of the three adherence and support strategies. Arm 1 is the standard of care arm as outlined by the Ministry of Health, Arm 2 is facility level support by a peer educator and Arm 3 is community level support by a peer educator.

• Study Type: Interventional
• Enrollment (Anticipated): 1050
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malawi
  • Lilongwe, Malawi
    • Recruiting
    • Ministry of Health facilities
    • Principal Investigator: Sam Phiri, Ph.D., MSc
    • Sub-Investigator: Hannock Tweya, MSc.,BSc.
    • Sub-Investigator: Erik Schouten, M.D.
    • Sub-Investigator: Michael Eliya, MPH
    • Sub-Investigator: Frank Chibwandira, MBBS, MPH
    • Sub-Investigator: Fabian Cataldo, PhD
    • Sub-Investigator: Monique van Lettow, MPH, PhD
    • Sub-Investigator: Megan Landes, MD, MSc
    • Sub-Investigator: Mina Hosseinipour, MD, MPH
    • Sub-Investigator: Nora Rosenberg, PhD, MSc.
    • Sub-Investigator: Innocent Mofolo, MA
    • Sub-Investigator: Levison Chiwaula, BSc, MA, PhD
    • Sub-Investigator: Atupele Kapito-Tembo, MBBS, PhD
    • Sub-Investigator: Veena Sampathkumar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• HIV infected women Presenting for Antenatal Care, Labor&Delivery, or post-partum Infants of Enrolled mothers Husbands/Spouses of Enrolled mothers

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Facility-based Peer Support; Facility-based Peer Support to provide the following at the clinic; Routine standard clinical care based on the MoH guidelines; Mentor mothers provide education and psychosocial support at facility; Weekly support groups provided in clinic; Phone call, SMS, or home visit for each missed appointment	Other: Facility-based Peer Support; Facility-based Peer Support to provide the following at the clinic Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment
Other: Community-based Peer Support; Community-based Support from Peer Mothers (Expert mothers): Routine standard clinical care based on the MoH guidelines; Mentor mothers provide education and psychosocial support in community prior to each visit; Monthly support groups in community; Home visits for each missed appointment	Other: Community based peer support; Community-based Support from Peer Mothers (Expert mothers): Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment
No Intervention: Standard of Care; The Standard of care as outlined in the Malawi HIV integrated Care Guidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention in Care	The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.	12 months post ART initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention at 24 months	The proportion of Women alive and retained on ART at 24 months post ART initiation	24 months post ART initiation
Child HIV status	Children tested at 6 weeks, 12 months, and 24 months	6 weeks, 12 months, 24 months
HIV free survival	HIV-free infant survival at 6-weeks, 12 months and 24 months	6 weeks, 12 months, 24 months
Family retention	Partner/family involvement, including: a) husband/children tested for HIV; b. eligible husbands/children who start ART; c. husband/children engaged in care at 12 months	12 months
Maternal Viral Load	Proportion of women with HIVRNA <1000 copies at 6 months and 2 years post initiation	6 months and 2 years post ART initiation
Maternal resistance	Of women failing ART, the proportion with HIV drug resistance	6 months, 2 years
Infant HIV resistance	Of HIV infected infants, the proportion with HIV drug resistance	6 weeks, 12 months, 24 months
Social outcomes	Social outcomes, including impact of task shifting on burden of care in facilities, quality of life for patients and their families, disclosure and shifts in boundaries of professional and lay care for lay health care workers as assessed by mixed methodology.	12, 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economics	Economic indicators including cost effectiveness ratios of support models, equity of access to PMTCT services by geographic area, socio-economic profiles of mothers and families accessing care to assess equity, and indicators for health system impacts such as time at work, overtime, number and types of cases treated, motivation and satisfaction by health workers as assessed by mixed methodology.	baseline, 12, 24 months

Collaborators and Investigators

• Sponsor: Lighthouse Trust
• Collaborators: University of North Carolina, Chapel Hill; World Health Organization; Kamuzu University of Health Sciences; University of Malawi; Ministry of Health and Population, Malawi; Dignitas International; AIDS Fonds; Mothers2Mothers; MSH (Management Sciences for Health)
• Investigators: Principal Investigator: Sam Phiri, PhD, MSc., Lighthouse Trust

Publications and helpful links

General Publications

• van Lettow M, Tweya H, Rosenberg NE, Trapence C, Kayoyo V, Kasende F, Kaunda B, Hosseinipour MC, Eliya M, Cataldo F, Gugsa S, Phiri S; PURE Malawi consortium. Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi. Reprod Health. 2017 Jul 11;14(1):82. doi: 10.1186/s12978-017-0343-0.
• Cataldo F, Sam-Agudu NA, Phiri S, Shumba B, Cornelius LJ, Foster G. The Roles of Expert Mothers Engaged in Prevention of Mother-to-Child Transmission (PMTCT) Programs: A Commentary on the INSPIRE Studies in Malawi, Nigeria, and Zimbabwe. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S224-S232. doi: 10.1097/QAI.0000000000001375.
• Hosseinipour M, Nelson JAE, Trapence C, Rutstein SE, Kasende F, Kayoyo V, Kaunda-Khangamwa B, Compliment K, Stanley C, Cataldo F, van Lettow M, Rosenberg NE, Tweya H, Gugsa S, Sampathkumar V, Schouten E, Eliya M, Chimbwandira F, Chiwaula L, Kapito-Tembo A, Phiri S; PURE Malawi Consortium. Viral Suppression and HIV Drug Resistance at 6 Months Among Women in Malawi's Option B+ Program: Results From the PURE Malawi Study. J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2(Suppl 2):S149-S155. doi: 10.1097/QAI.0000000000001368.
• Phiri S, Tweya H, van Lettow M, Rosenberg NE, Trapence C, Kapito-Tembo A, Kaunda-Khangamwa B, Kasende F, Kayoyo V, Cataldo F, Stanley C, Gugsa S, Sampathkumar V, Schouten E, Chiwaula L, Eliya M, Chimbwandira F, Hosseinipour MC; PURE Malawi Consortium. Impact of Facility- and Community-Based Peer Support Models on Maternal Uptake and Retention in Malawi's Option B+ HIV Prevention of Mother-to-Child Transmission Program: A 3-Arm Cluster Randomized Controlled Trial (PURE Malawi). J Acquir Immune Defic Syndr. 2017 Jun 1;75 Suppl 2:S140-S148. doi: 10.1097/QAI.0000000000001357.
• Cataldo F, Chiwaula L, Nkhata M, van Lettow M, Kasende F, Rosenberg NE, Tweya H, Sampathkumar V, Hosseinipour M, Schouten E, Kapito-Tembo A, Eliya M, Chimbwandira F, Phiri S; PURE Malawi Consortium. Exploring the Experiences of Women and Health Care Workers in the Context of PMTCT Option B Plus in Malawi. J Acquir Immune Defic Syndr. 2017 Apr 15;74(5):517-522. doi: 10.1097/QAI.0000000000001273.
• Chiwaula LS, Chirwa GC, Cataldo F, Kapito-Tembo A, Hosseinipour MC, van Lettow M, Tweya H, Kayoyo V, Khangamwa-Kaunda B, Kasende F, Trapence C, Gugsa S, Rosenberg NE, Eliya M, Phiri S; PURE Malawi Consortium. The value of informal care in the context of option B+ in Malawi: a contingent valuation approach. BMC Health Serv Res. 2016 Apr 19;16:136. doi: 10.1186/s12913-016-1381-y. Erratum In: BMC Health Serv Res. 2017 Mar 10;17 (1):191.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: December 4, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (Estimate): December 9, 2013

Study Record Updates

• Last Update Posted (Estimate): December 9, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: HIV; Option B+; Prevention of Mother to Child Transmission
• Other Study ID Numbers: PUREMalawi