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

HIV/AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03127397
• Other study ID #: SERO-061-03-2017
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2017
• Last updated: April 9, 2018
• Start date: April 20, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: April 2018
• Source: Reed College
• Contact: Nicholas Wilson, Ph.D.
• Phone: 503-517-7733
• Email: nwilson[@]reed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 810
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• HIV/AIDS

Intervention

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

Locations

Country	Name	City	State
Ethiopia	Addis Ababa	Addis Ababa

Sponsors (3)

Lead Sponsor	Collaborator
Reed College	Population Services International, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention in care at 1 month		1 month
Primary	ART adherence at 1 month		1 month
Primary	Retention in care at 3 months		3 months
Primary	ART adherence at 3 months		3 months
Primary	Retention in care at 6 months		6 months
Primary	ART adherence at 6 months		6 months
Primary	Viral suppression at 6 months		6 months