Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia

NCT ID: NCT03127397

Last Updated: 2018-04-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 810 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2018-07-30

Brief Summary

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

Detailed Description

This study evaluates the effects of praise message phone calls on antiretroviral therapy (ART) initiation, adherence, and prescription refills. The investigators will use randomization to assign newly (diagnosed) HIV positive, ART naive, female sex workers (FSWs) in Ethiopia to a praise message phone call study arm or to a standard of care control study arm.

Inadequate adherence to ART medication, missed clinics visits and loss-to-follow-up, and failure to refill prescriptions are major barriers to achieving viral suppression. Non-adherence is associated with a range of individual, social, community, and structural factors, including low health literacy, a lack of social support, low socioeconomic status, substance abuse, stigma and discrimination, and a lack of access to a reliable source of ART drugs. ART patients' perceptions about a lack of health provider respect and mutual trust are a possible further barrier to adherence.

Provision of HIV therapy within the MULU/MARPs drop-in-centers has attempted to mitigate some of the structural and social barriers to ART initiation and retention in care by bringing FSW friendly treatment services closer to clients and providing intensive counseling services, social and economic support services, and referrals to additional health services. Improving client perceptions of health care provider attitudes may further improve retention in care and adherence to treatment among FSW in Ethiopia. This study will measure the effects of praise message phone calls delivered the day after, and two weeks after, completing a ART appointment (i.e. initiation and/or prescription refill) on subsequent ART refills/HIV clinic visits.

This study will be conducted within PSI/Ethiopia's USAID-funded MULU/MARPs program, which provides HIV testing, treatment, and other services to female sex workers (FSW) through a network of drop-in-centers (DICs) across Ethiopia. Consenting FSWs who are living with HIV, who are ART naive, and who are referred for ART initiation to one of the 25 drop-in-centers (DICs) selected for "Test and Start" implementation will be enrolled in the study. Pre-study analysis indicates that each DIC enrolls between 3-4 FSWs living with HIV on ART each month (mean: 3.6). Over the course of our 9 month study, the investigators expect to enroll a total of 810 study participants.

Conditions

HIV/AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Praise Message

Receives up to two praise message phone calls after each completed ART appointment.

Group Type: EXPERIMENTAL

Praise message phone call

Intervention Type: BEHAVIORAL

Praise message phone calls after each completed ART appointment, up to two calls per month.

Interventions

Praise message phone call

Praise message phone calls after each completed ART appointment, up to two calls per month.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Written consent,
• ART naive,
• Female sex worker,
• Living with HIV,
• And, seeking care at a participating clinic

Exclusion Criteria

• No consent,
• Previous ART,
• Has not exchanged sex for money in past 12 months,
• HIV negative,
• And/or, has not sought care at a participating clinic

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Population Services International

OTHER

Sponsor Role: collaborator

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Reed College

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Wilson

Associate Professor of Economics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Addis Ababa

Addis Ababa, , Ethiopia

Site Status: RECRUITING

Countries

Ethiopia

Central Contacts

Nicholas Wilson, Ph.D.

Role: CONTACT

nwilson@reed.edu

503-517-7733

Facility Contacts

Woldemariam Girma

Role: primary

wgirma@psiet.org

Other Identifiers

SERO-061-03-2017

Identifier Type: -

Identifier Source: org_study_id