Adolescent Behavior, Health Behavior, HIV/AIDS, Medication Adherence
Conditions
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.
Interventions
BEHAVIORALOnline 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
Sponsors
FHI 360
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Single group pre/post design
Eligibility
Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Active Members Who Have at Least One Post in Group Chat Session. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Score | 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. |
| Adherence to ART as Measured by the AACTG Adherence Assessment | 3 months | 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 | 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. |
Countries
Nigeria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Online Support Group Intervention content was delivered online through secret Facebook groups that limit membership and access to those invited and added by a group administrator. Intervention components included informational messages and moderated group discussions. Five sessions were included: 1) Understanding HIV; 2) Disclosure and Developing Trust in Relationships; 3) Treatment and Adherence; 4) Nutrition and Health; and 5) Sex and Relationships. Sessions activities included: 1) At-a-glance, introducing the topic of the week; 2) Word of the week, defining one key concept for the topic; 3) Cartoons used to tell a story related to the topic; 4) Key messages to deliver important information; 5) Quizzes to assess participants' knowledge and stimulate discussion; and 6) Group discussions moderated by facilitators. Groups began with an initial, in-person meeting. All participants received a basic cellular phone that could access Facebook, regardless of current phone ownership. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Literacy precluded participation | 1 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Online Support Group | — |
|---|---|---|
| Age, Continuous | 17 Years | — |
| Currently employed | 11 Participants | — |
| Education Currently enrolled in school, junior or secondary | 5 Participants | — |
| Education Currently enrolled in school, post-secondary | 15 Participants | — |
| Education Not currently enrolled, completed some secondary | 6 Participants | — |
| Education Not currently enrolled, complete secondary | 15 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Nigeria | 41 participants | — |
| religion All other Christian | 40 Participants | — |
| religion Catholic | 1 Participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
| Time on ART | 3.8 Years | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 41 |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
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.
Time frame: 3 months
Population: Participants who initiated the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Support Group | Percentage of Active Members Who Have at Least One Post in Group Chat Session. | 32 Participants |
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.
Time frame: 3 months
Population: Endline participants who participated in the intervention
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Online Support Group | Acceptability Score | 9.9 Scores on Scale |
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.
Time frame: 3 months
Population: Participants who completed end line questionnaire
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Support Group | Adherence to ART as Measured by the AACTG Adherence Assessment | 29 Participants |
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.
Time frame: 3 months
Population: Participants enrolled in study at baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Online Support Group | Adherence to Follow-up Visit Within 1 Month of Scheduled Date | 37 Participants |