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Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria

Primary Purpose

HIV/AIDS, Adolescent Behavior, Medication Adherence

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Online support group
Sponsored by
FHI 360
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for HIV/AIDS

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • HIV positive and currently on ART for at least 6 months
  • Age 15 to 19 years
  • Can demonstrate basic literacy necessary to participate in online chats

Exclusion Criteria:

  • Not planning to remain in the study area (within Akwa Ibom State) for the duration of the study (approximately 6 months)
  • Currently enrolled in an in-person support group
  • Currently enrolled in another research study related to HIV service retention or ART adherence
  • Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment

Sites / Locations

  • SIDHAS-supported facilities

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Online support group

Arm Description

Participants will be enrolled to receive six sessions from the Positive Connections curriculum through the m/eHealth intervention that will use Facebook to conduct online structured support groups.

Outcomes

Primary Outcome Measures

Percentage of Active Members Who Have at Least One Post in Group Chat Session.
Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session.

Secondary Outcome Measures

Acceptability Score
Acceptability score: A set of ten items asking if participants agreed=1 or disagreed=0 with statements on acceptability. Score represents a sum of the 10 items with a range of 0 to 10, and a greater number indicating agreement with more acceptability items.
Adherence to ART as Measured by the AACTG Adherence Assessment
Proportion of participants who report not having missed any ART doses in past 3 days.
Adherence to Follow-up Visit Within 1 Month of Scheduled Date
Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place.

Full Information

First Posted
February 8, 2017
Last Updated
February 15, 2019
Sponsor
FHI 360
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1. Study Identification

Unique Protocol Identification Number
NCT03076996
Brief Title
Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
Official Title
Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 15, 2018 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FHI 360

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 will examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services.
Detailed Description
Study aim is to examine the feasibility and acceptability of an intervention designed to improve retention in HIV care services and improve anti-retroviral therapy (ART) adherence among adolescents ages 15-19 years living with HIV enrolled in ART services. A single group, pre/posttest design including structured questionnaires with adolescents living with HIV. Additionally, we will abstract clinical data from the medical record system. We will also conduct in-depth interviews with a subset of participants, as well as health care staff who are engaged in the intervention, at endline. The objectives of this study are: To examine the feasibility of implementing a mobile/electronic health (m/eHealth) intervention designed to improve retention in HIV care services and ART adherence among ALHIV ages 15-19 years through an online support group (using Facebook). To assess acceptability of and engagement in the intervention by the target audience to inform improvements to the intervention. To gather preliminary data on the psycho-social and health-related outcomes that the intervention is designed to affect to inform an outcome evaluation study that will be conducted following the conclusion of the feasibility study. To collect information on recruitment, informed consent and data collection processes to inform the outcome evaluation study of the current intervention that will be conducted once findings from this feasibility study are incorporated into the intervention design.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Adolescent Behavior, Medication Adherence, Health Behavior

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single group pre/post design
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Online support group
Arm Type
Experimental
Arm Description
Participants will be enrolled to receive six sessions from the Positive Connections curriculum through the m/eHealth intervention that will use Facebook to conduct online structured support groups.
Intervention Type
Behavioral
Intervention Name(s)
Online support group
Intervention Description
Participants will be enrolled to form five groups of 8 to 10 participants, and then participants will participate in the 6 sessions of the structured educational and group counseling curriculum through the online platform. The m/eHealth intervention components include: Informational messages that reflect the content of the structured group counseling curriculum, Positive Connections, and are posted to the group wall on a regular basis Moderated, closed group chats where ALHIV can interact with their peers and with a trained health counselor on a biweekly basis Access to a trained counselor via Facebook Messenger (during normal business hours) for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed
Primary Outcome Measure Information:
Title
Percentage of Active Members Who Have at Least One Post in Group Chat Session.
Description
Participants level of engagement in support group activities informs on the feasibility of intervention, measured by percentage of active members who have at least one post in group chat session.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Acceptability Score
Description
Acceptability score: A set of ten items asking if participants agreed=1 or disagreed=0 with statements on acceptability. Score represents a sum of the 10 items with a range of 0 to 10, and a greater number indicating agreement with more acceptability items.
Time Frame
3 months
Title
Adherence to ART as Measured by the AACTG Adherence Assessment
Description
Proportion of participants who report not having missed any ART doses in past 3 days.
Time Frame
3 months
Title
Adherence to Follow-up Visit Within 1 Month of Scheduled Date
Description
Retention in HIV services will be measured using data abstracted from the medical record system on date of visits between enrollment and the endline of this study. To be considered retained in HIV services, an individual must, at 3 months after enrollment, have attended his/her most recently scheduled clinical follow-up visit within 1 month of the date when it was scheduled to take place.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: HIV positive and currently on ART for at least 6 months Age 15 to 19 years Can demonstrate basic literacy necessary to participate in online chats Exclusion Criteria: Not planning to remain in the study area (within Akwa Ibom State) for the duration of the study (approximately 6 months) Currently enrolled in an in-person support group Currently enrolled in another research study related to HIV service retention or ART adherence Critically or severely ill requiring hospitalization or such that the individual is unable to provide informed consent at the time of study recruitment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa S Dulli, PhD
Organizational Affiliation
FHI 360
Official's Role
Principal Investigator
Facility Information:
Facility Name
SIDHAS-supported facilities
City
Uyo
State/Province
Always Ibom
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30487116
Citation
Dulli L, Ridgeway K, Packer C, Plourde KF, Mumuni T, Idaboh T, Olumide A, Ojengbede O, McCarraher DR. An Online Support Group Intervention for Adolescents Living with HIV in Nigeria: A Pre-Post Test Study. JMIR Public Health Surveill. 2018 Nov 28;4(4):e12397. doi: 10.2196/12397.
Results Reference
derived

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Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria

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