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

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ClinicalTrials.gov Identifier: NCT03127397
Recruitment Status : Recruiting
First Posted : April 25, 2017
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
Population Services International
United States Agency for International Development (USAID)
Information provided by (Responsible Party):
Nicholas Wilson, Reed College

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 20, 2017
Estimated Primary Completion Date : July 30, 2018
Estimated Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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.




Primary Outcome Measures :
  1. Retention in care at 1 month [ Time Frame: 1 month ]
  2. ART adherence at 1 month [ Time Frame: 1 month ]
  3. Retention in care at 3 months [ Time Frame: 3 months ]
  4. ART adherence at 3 months [ Time Frame: 3 months ]
  5. Retention in care at 6 months [ Time Frame: 6 months ]
  6. ART adherence at 6 months [ Time Frame: 6 months ]
  7. Viral suppression at 6 months [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03127397


Contacts
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Contact: Nicholas Wilson, Ph.D. 503-517-7733 nwilson@reed.edu

Locations
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Ethiopia
Addis Ababa Recruiting
Addis Ababa, Ethiopia
Contact: Woldemariam Girma       wgirma@psiet.org   
Sponsors and Collaborators
Reed College
Population Services International
United States Agency for International Development (USAID)

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Responsible Party: Nicholas Wilson, Associate Professor of Economics, Reed College
ClinicalTrials.gov Identifier: NCT03127397     History of Changes
Other Study ID Numbers: SERO-061-03-2017
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicholas Wilson, Reed College:
antiretroviral therapy
HIV/AIDS
ART adherence