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

February 15, 2019 updated by: FHI 360
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

  1. 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).
  2. To assess acceptability of and engagement in the intervention by the target audience to inform improvements to the intervention.
  3. 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.
  4. 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Always Ibom
      • Uyo, Always Ibom, Nigeria
        • SIDHAS-supported facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Online support group
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.
Behavioral: Online support group

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Active Members Who Have at Least One Post in Group Chat Session.
Time Frame: 3 months
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability Score
Time Frame: 3 months
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.
3 months
Adherence to ART as Measured by the AACTG Adherence Assessment
Time Frame: 3 months
Proportion of participants who report not having missed any ART doses in past 3 days.
3 months
Adherence to Follow-up Visit Within 1 Month of Scheduled Date
Time Frame: 3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Investigators

  • Principal Investigator: Lisa S Dulli, PhD, FHI 360

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

January 15, 2018

Study Completion (Actual)

January 15, 2018

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

March 9, 2017

First Posted (Actual)

March 10, 2017

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 15, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 930307

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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