Trial Outcomes & Findings for Youth Power Action Feasibility Study of Online Support Group Intervention Among Adolescents Living With HIV in Nigeria (NCT NCT03076996)

Last Updated: 2019-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

41 participants

Primary outcome timeframe

3 months

Results posted on

2019-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	41
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3
Overall Study Literacy precluded participation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Online Support Group n=41 Participants 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.
Age, Continuous	17 Years n=41 Participants
Sex: Female, Male Female	22 Participants n=41 Participants
Sex: Female, Male Male	19 Participants n=41 Participants
Region of Enrollment Nigeria	41 participants n=41 Participants
religion Catholic	1 Participants n=41 Participants
religion All other Christian	40 Participants n=41 Participants
Time on ART	3.8 Years n=41 Participants
Education Currently enrolled in school, junior or secondary	5 Participants n=41 Participants
Education Currently enrolled in school, post-secondary	15 Participants n=41 Participants
Education Not currently enrolled, completed some secondary	6 Participants n=41 Participants
Education Not currently enrolled, complete secondary	15 Participants n=41 Participants
Currently employed	11 Participants n=41 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants who initiated the intervention

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.

Outcome measures

Outcome measures
Measure	Online Support Group n=38 Participants 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.
Percentage of Active Members Who Have at Least One Post in Group Chat Session.	32 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Endline participants who participated in the intervention

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.

Outcome measures

Outcome measures
Measure	Online Support Group n=34 Participants 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.
Acceptability Score	9.9 Scores on Scale Interval 9.0 to 10.0

SECONDARY outcome

Timeframe: 3 months

Population: Participants who completed end line questionnaire

Proportion of participants who report not having missed any ART doses in past 3 days.

Outcome measures

Outcome measures
Measure	Online Support Group n=35 Participants 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.
Adherence to ART as Measured by the AACTG Adherence Assessment	29 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Participants enrolled in study at baseline

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.

Outcome measures

Outcome measures
Measure	Online Support Group n=41 Participants 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.
Adherence to Follow-up Visit Within 1 Month of Scheduled Date	37 Participants

Adverse Events

Online Support Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lisa Dulli

FHI 360

Phone: 919-544-7040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place