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

Primary Purpose

HIV/AIDS

Status
Unknown status
Phase
Not Applicable
Locations
Ethiopia
Study Type
Interventional
Intervention
Praise message phone call
Sponsored by
Reed College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for HIV/AIDS focused on measuring antiretroviral therapy, HIV/AIDS, ART adherence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Addis AbabaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care

Praise Message

Arm Description

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

Outcomes

Primary Outcome Measures

Retention in care at 1 month
ART adherence at 1 month
Retention in care at 3 months
ART adherence at 3 months
Retention in care at 6 months
ART adherence at 6 months
Viral suppression at 6 months

Secondary Outcome Measures

Full Information

First Posted
April 20, 2017
Last Updated
April 9, 2018
Sponsor
Reed College
Collaborators
Population Services International, United States Agency for International Development (USAID)
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1. Study Identification

Unique Protocol Identification Number
NCT03127397
Brief Title
Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia
Official Title
Contribution of "Praise Messages" to HIV Treatment Retention and Adherence Among Female Sex Workers in Ethiopia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Anticipated)
Study Completion Date
July 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Reed College
Collaborators
Population Services International, United States Agency for International Development (USAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS
Keywords
antiretroviral therapy, HIV/AIDS, ART adherence

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
810 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Title
Praise Message
Arm Type
Experimental
Arm Description
Receives up to two praise message phone calls after each completed ART appointment.
Intervention Type
Behavioral
Intervention Name(s)
Praise message phone call
Intervention Description
Praise message phone calls after each completed ART appointment, up to two calls per month.
Primary Outcome Measure Information:
Title
Retention in care at 1 month
Time Frame
1 month
Title
ART adherence at 1 month
Time Frame
1 month
Title
Retention in care at 3 months
Time Frame
3 months
Title
ART adherence at 3 months
Time Frame
3 months
Title
Retention in care at 6 months
Time Frame
6 months
Title
ART adherence at 6 months
Time Frame
6 months
Title
Viral suppression at 6 months
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicholas Wilson, Ph.D.
Phone
503-517-7733
Email
nwilson@reed.edu
Facility Information:
Facility Name
Addis Ababa
City
Addis Ababa
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woldemariam Girma
Email
wgirma@psiet.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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