Promoting Uptake and Retention of Option B+ in Malawi

Not Applicable

• Conditions: HIV
• Interventions: Other: Facility-based Peer Support; Other: Community based peer support

• Registration Number: NCT02005835
• Lead Sponsor: Lighthouse Trust

Brief Summary

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.

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 Timeline

• Study Start: 2013-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Last Update Submitted: 2013-12-04
• Study First Posted: 2013-12-09
• Last Update Posted: 2013-12-09
• Primary Completion: 2015-05
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1050

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Facility-based Peer Support	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
Community-based Peer Support	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

Primary Outcome Measures

Name	Time	Method
Retention in Care	12 months post ART initiation	The primary outcome is the proportion of women retained alive and on ART at 12 months post ART initiation.

Secondary Outcome Measures

Name	Time	Method
HIV free survival	6 weeks, 12 months, 24 months	HIV-free infant survival at 6-weeks, 12 months and 24 months
Retention at 24 months	24 months post ART initiation	The proportion of Women alive and retained on ART at 24 months post ART initiation
Child HIV status	6 weeks, 12 months, 24 months	Children tested at 6 weeks, 12 months, and 24 months
Infant HIV resistance	6 weeks, 12 months, 24 months	Of HIV infected infants, the proportion with HIV drug resistance
Social outcomes	12, 24 months	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.
Family retention	12 months	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
Maternal Viral Load	6 months and 2 years post ART initiation	Proportion of women with HIVRNA \<1000 copies at 6 months and 2 years post initiation
Maternal resistance	6 months, 2 years	Of women failing ART, the proportion with HIV drug resistance

Trial Locations

Locations (1)

Ministry of Health Facilities; 🇲🇼 Lilongwe, Malawi