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

Sponsor

Reed College (Other)

Overall Status

Unknown status

CT.gov ID

NCT03127397

Collaborator

Population Services International (Other), United States Agency for International Development (USAID) (U.S. Fed)

810

Enrollment

Location

Arms

15.3

Anticipated Duration (Months)

52.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV/AIDS	Behavioral: Praise message phone call	N/A

Detailed Description

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 Design

Study Type:

Interventional

Anticipated Enrollment :

810 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Apr 20, 2017

Anticipated Primary Completion Date :

Jul 30, 2018

Anticipated Study Completion Date :

Jul 30, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Addis Ababa	Addis Ababa		Ethiopia

Sponsors and Collaborators

Reed College
Population Services International
United States Agency for International Development (USAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nicholas Wilson, Associate Professor of Economics, Reed College

ClinicalTrials.gov Identifier:

NCT03127397

Other Study ID Numbers:

SERO-061-03-2017

First Posted:

Apr 25, 2017

Last Update Posted:

Apr 10, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Nicholas Wilson, Associate Professor of Economics, Reed College

antiretroviral therapy

HIV/AIDS

ART adherence

Additional relevant MeSH terms:

Acquired Immunodeficiency Syndrome

HIV Infections

Study Results

No Results Posted as of Apr 10, 2018