Digital Peer-support-based Anti-HIV Stigma Intervention Among Adolescents Living With HIV in Ethiopia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-22
SponsorLund University
About this trial
Advances in HIV care and treatment turned a once deadly disease into a chronic condition where people living with HIV, including perinatally HIV acquired children, can now lead a healthy life and live longer with their highly effective antiretroviral therapy. Despite the advancements and successes in HIV care and treatment, HIV-related stigma remained a challenge to people living with HIV and for the provision of the available successful treatment and support. Stigma and discrimination related to HIV infection inhibit health-seeking behaviour, clinical outcomes, physical and psychosocial wellbeing and is a major obstacle for timely diagnosis.
Peer support programs to people living with HIV appeared to have improved self-confidence of members and consequently reduced self-stigma and improved their coping ability against external stigma. However, these services are limited in terms of geography owing to lack of adequate financing to cover operational costs for adolescents coming from rural areas and space and facility limitation to accommodate large groups.
The eHealth services have potential to provide some of the services offered in the in-person sessions of the peer support group. Despite this important potential of eHealth services, they are underutilized and are not often used to target HIV-related stigma in adolescents living with HIV. The present study will investigate whether the digital peer-support anti-HIV stigma reduces internalized and anticipated stigma among adolescents living with HIV (ALHIV) in South Ethiopia. Further, we will explore the health-related outcomes including adolescent's psychological wellbeing, retention in care and sustained viral load suppression.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adolescents who have been disclosed of their HIV status
adolescents and young people between the age of 15 and 22 years old
receiving antiretroviral medications; and
completed at least first cycle primary school education (i.e. grade 4).
Disqualifiers
Participants with known diagnosed mental health condition
Participants with hearing loss or loss of vision
Trial design
Design model
Parallel
Treatments tested in this trial
Peer support based digital anti-HIV stigma intervention
BehavioralParticipants in the intervention arm will remotely attend educational sessions facilitated by peer leaders and supervised by healthcare providers and members of the research team. They will receive audiovisual content as part of modules (two modules in 12 sessions) designed to enhance both individual and social life skills. The intervention group will be organized into seven groups, each consisting at most 20 participants. Peer leaders, who received training on facilitation skills, will facilitate discussions on the session topics, with each session expected to last about one hour. To bridge the digital divide, the research team will provide smartphones to participants to support online discussions via the Telegram messaging platform. Technical orientation on using the Telegram app for discussions will be provided to all participants, regardless of their prior experience with the platform. Internet data for connectivity will be secured every fortnightly over the period of 16 weeks.
A standard in-clinic in-person psychosocial support
BehavioralIn arm 2, the control arm, participants will receive the existing psychosocial support routinely provided in the hospitals where they receive care. As part of this in-clinic peer support, adolescents living with HIV meet monthly to sit together and discuss a topic under the supervision of an assigned healthcare provider. After the discussion, they spend time playing together, followed by sharing a meal before departing, with a small transport allowance provided.
Treatment groups
282 Participants
are divided into 2 treatment groupsGroup A: Digital peer supportExperimental treatment 2 interventions
Group B: In-person peer supportActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
HIV-related stigma: internalised and anticipated
The Brief HIV Stigma Scale-12, translated into Amharic and validated for use in the Ethiopian context, will be employed to assess HIV-related stigma among adolescents living with HIV. The tool comprises 12 items measuring four constructs, each represented by three items. Responses are rated on a four-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 12 to 48, with higher scores indicating greater levels of stigma (i.e., worse outcomes).
Time frame
From enrollment at baseline to the end of intervention at 16 weeks.Secondary outcomes
1
Psychological well-being
1\. Psychological well-being will be assessed using measures of depression and anxiety. Depression will be measured with the Patient Health Questionnaire-9 (PHQ-9), a nine-item scale scored from 0 ("never at all") to 3 ("nearly everyday"), with total scores ranging from 0 to 27; higher scores indicate worse depressive symptoms. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), which uses the same response format (0 to 3) and yields scores from 0 to 21, with higher values indicating severe anxiety symptoms. Psychological well-being will be defined as "good" and "poor". Participants with PHQ-9 and GAD-7 scores\<10 will be classified as having good psychological well-being; others will be classified as poor.
Time frame
From enrollment at baseline to the end of intervention at 16 weeks.2
Retention in care
1\. Retention in HIV care will be measured as the proportion of kept clinic visits out of the total scheduled visits during the 12 months preceding the assessment period.
Time frame
From enrollment at baseline to the end of intervention at 16 weeks.Sponsors and contacts
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Source ClinicalTrials.gov