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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03076996
• Other study ID #: 930307
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: January 15, 2018

Study information

• Verified date: February 2019
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 15, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Health Behavior
• HIV/AIDS
• Medication Adherence

Intervention

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

Locations

Country	Name	City	State
Nigeria	SIDHAS-supported facilities	Uyo	Always Ibom

Sponsors (1)

Lead Sponsor	Collaborator
FHI 360

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months
Secondary	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.	3 months