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

Lighthouse Trust

Status: Unknown

Conditions: HIV

Treatments: Other: Facility-based Peer Support; Other: Community based peer support

Study type: Interventional

Funder types: Other

Identifiers

NCT02005835

PUREMalawi

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,050 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,050 participants in 3 patient groups

Facility-based Peer Support

Other group

Description:

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

Treatment:

Other: Facility-based Peer Support

Community-based Peer Support

Other group

Description:

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

Treatment:

Other: Community based peer support

Standard of Care

No Intervention group

Description:

The Standard of care as outlined in the Malawi HIV integrated Care Guidelines