Clinical trial NCT03076996: 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
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
Adolescent Behavior
Medication Adherence
Health Behavior
Lead sponsor: FHI 360
Sponsor class: OTHER
First posted: 2017-03-10
Enrollment: 41
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group pre/post design
Primary purpose: SUPPORTIVE_CARE

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:

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.

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

Primary outcomes:
measure: Percentage of Active Members Who Have at Least One Post in Group Chat Session.
timeFrame: 3 months
Secondary outcomes:
measure: Acceptability Score
timeFrame: 3 months
measure: Adherence to ART as Measured by the AACTG Adherence Assessment
timeFrame: 3 months
measure: Adherence to Follow-up Visit Within 1 Month of Scheduled Date
timeFrame: 3 months
Other outcomes:
Locations:
city: Uyo
country: Nigeria
facility: SIDHAS-supported facilities
state: Always Ibom
Study officials:
affiliation: FHI 360
name: Lisa S Dulli, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.