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

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.

Study Overview

• Status: Unknown
• Conditions: HIV/AIDS
• Intervention / Treatment: Behavioral: Praise message phone call

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.

• Study Type: Interventional
• Enrollment (Anticipated): 810
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas Wilson, Ph.D.; Phone Number: 503-517-7733; Email: nwilson@reed.edu

Study Locations

• Ethiopia
  • Addis Ababa, Ethiopia
    • Recruiting
    • Addis Ababa
    • Contact: Woldemariam Girma; Email: wgirma@psiet.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care
Experimental: Praise Message; Receives up to two praise message phone calls after each completed ART appointment.	Behavioral: Praise message phone call; Praise message phone calls after each completed ART appointment, up to two calls per month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Retention in care at 1 month	1 month
ART adherence at 1 month	1 month
Retention in care at 3 months	3 months
ART adherence at 3 months	3 months
Retention in care at 6 months	6 months
ART adherence at 6 months	6 months
Viral suppression at 6 months	6 months

Collaborators and Investigators

• Sponsor: Reed College
• Collaborators: United States Agency for International Development (USAID); Population Services International

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2017
• Primary Completion (Anticipated): July 30, 2018
• Study Completion (Anticipated): July 30, 2018

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 25, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: April 9, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: HIV/AIDS; antiretroviral therapy; ART adherence
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: SERO-061-03-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No