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Table 5 Implications of the feasibility assessment on the Harambee cluster randomized trial design

From: Integrating community-based HIV and non-communicable disease care with microfinance groups: a feasibility study in Western Kenya

Concept

Original study criterion

Barrier identified during feasibility study

Opportunity identified during feasibility study

Criterion adaptation

Inclusion criteria (group-level)

Predominantly HIV-positive GISE groups

GISE groups have either evolved into mixed groups or turned dormant

____

Opening up the intervention to community-based HIV groups that engage in microfinance activities

Inclusion criteria (individual-level)

HIV-positive adults

National HIV guidelines outline patient’s eligibility for participation in community-based ART groups

____

(1) HIV-positive. However should:

- Be virally suppressed

- Not be pregnant

- Not be a member of a CAG

- Have no active opportunistic infection/other serious comorbidity such as cancer.

(2) Development of a protocol on handling virally unsuppressed participants

Definition of active membership at the group level

Have participated in at least one microfinance group meeting in the prior 12 months at study baseline

Groups define active membership differently

_____

Have participated in at least one microfinance group meeting in the prior 6 months at study baseline

Clinical team

Team to comprise of clinical officers, pharmaceutical technologists, social workers and peer mentors, on a full-time basis.

Low confidence in clinicians’ ability to adequately conduct some procedures such as drawing blood for viral load testing.

(1) Study to rely on existing structures such as the county-based riders program and CHVs.

(1) Study to employ phlebotomists.

(2) Study to work with the county-based riders on sample collection and delivery.

  1. GISE Group Integrated Savings for Empowerment [interchangeably also called microfinance groups], CAG community ART group, CHVs community health volunteers