NCT07425925

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

November 24, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

digital peer-supportHIV-related stigmaadolescents living with HIVsouth Ethiopia

Outcome Measures

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).

    From enrollment at baseline to the end of intervention at 16 weeks.

Secondary Outcomes (2)

  • Psychological well-being

    From enrollment at baseline to the end of intervention at 16 weeks.

  • Retention in care

    From enrollment at baseline to the end of intervention at 16 weeks.

Study Arms (2)

Digital peer support

EXPERIMENTAL

In the digital peer support arm, adolescents and youth living with HIV will be networked digitally to share their experiences and receive a structured educational message designed based on literature review and also referring the national psychosocial support guidelines. Adolescents and youth who don't have smartphones will be offered with one to enable them connect digitally. Brief orientation about the Telegram messaging app will be provided to all participants in the intervention arm to close any digital divide. Two modules (individual life skills module and the social mastery skills module) in 12 sessions (module 1: introduction, goal-setting, decision-making, myths and misconceptions about HIV, self-acceptance, self-care, resilience; module 2: coping skills, communication skills, onward disclosure of HIV status, understanding stigma language, and building relationship) will be offered over 16 weeks.

Behavioral: Peer support based digital anti-HIV stigma interventionBehavioral: A standard in-clinic in-person psychosocial support

In-person peer support

ACTIVE COMPARATOR

In the in-clinic in-person peer support, adolescents and youth living with HIV meet in-person fortnightly and share experiences and receive peer led lessons based on the national psychosocial support module. They also had time to spend together playing and eating lunch. Furthermore, they receive a small amount of fee to cover transport.

Behavioral: A standard in-clinic in-person psychosocial support

Interventions

Participants 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.

Digital peer support

In 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.

Digital peer supportIn-person peer support

Eligibility Criteria

Age14 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Participants with known diagnosed mental health condition
  • Participants with hearing loss or loss of vision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Arba Minch General Hospital

Arba Minch, South Ethiopia, Ethiopia

COMPLETED

Dilla University Teaching Hospital

Dara, South Ethiopia, Ethiopia

RECRUITING

Sawula General Hospital

Gofa, South Ethiopia, Ethiopia

RECRUITING

Jinka General Hospital

Jinka, South Ethiopia, Ethiopia

RECRUITING

Wolaita Sodo University Comprehensive Specialized Hospital

Sodo, South Ethiopia, Ethiopia

COMPLETED

Related Publications (15)

  • Levis B, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) Collaboration. Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 9;365:l1476. doi: 10.1136/bmj.l1476.

    PMID: 30967483BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Kane, J.C. et al. (2019) 'A scoping review of health-related stigma outcomes for high-burden diseases in low- and middle-income countries', BMC Medicine, 17(1), p. 17. Available at: https://doi.org/10.1186/s12916-019-1250-8.

    BACKGROUND
  • Dyer, J. et al. (2021) 'The Psychosocial Effects of the COVID-19 Pandemic on Youth Living with HIV in Western Kenya', AIDS and behavior, 25(1), pp. 68-72. Available at: https://doi.org/10.1007/s10461-020-03005-x.

    BACKGROUND
  • Chem, E.D. et al. (2022) 'Health-related needs reported by adolescents living with HIV and receiving antiretroviral therapy in sub-Saharan Africa: a systematic literature review', Journal of the International AIDS Society, 25(8), p. e25921. Available at: https://doi.org/10.1002/JIA2.25921.

    BACKGROUND
  • Mark, D. et al. (2019) 'Peer Support for Adolescents and Young People Living with HIV in sub-Saharan Africa: Emerging Insights and a Methodological Agenda', Current HIV/AIDS Reports, 16(6), pp. 467-474. Available at: https://doi.org/10.1007/s11904-019-00470-5.

    BACKGROUND
  • Biru, M. et al. (2018) 'Hope for the Future But Fear the Risk of Stigma: Ethiopian Family Caregivers' Lived Experience of Caring for Their HIV Positive Child Two Years After Starting Antiretroviral Treatment', Comprehensive Child and Adolescent Nursing, 41(4), pp. 293-309. Available at: https://doi.org/10.1080/24694193.2017.1372531.

    BACKGROUND
  • Andersson, G.Z. et al. (2020) 'Stigma reduction interventions in people living with HIV to improve health-related quality of life.', The lancet. HIV, 7(2), pp. e129-e140. Available at: https://doi.org/10.1016/S2352-3018(19)30343-1.

    BACKGROUND
  • Rao, D., Frey, S. and Ramaiya, M. (2018) 'eHealth for Stigma Reduction Efforts Designed to Improve Engagement in Care for People Living with HIV', Current HIV/AIDS Reports, 15(6), pp. 397-402. Available at: https://doi.org/10.1007/s11904-018-0414-z.

    BACKGROUND
  • Simpson, N. et al. (2021) 'Insaka: mobile phone support groups for adolescent pregnant women living with HIV', BMC pregnancy and childbirth, 21(1), pp. 663-663. Available at: https://doi.org/10.1186/s12884-021-04140-6.

    BACKGROUND
  • Mburu, G. et al. (2013) 'Resisting and challenging stigma in Uganda: the role of support groups of people living with HIV', Journal of the International AIDS Society, 16(3S2), p. 18636. Available at: https://doi.org/10.7448/IAS.16.3.18636.

    BACKGROUND
  • Sweeney SM and Vanable PA (2016) 'The Association of HIV-Related Stigma to HIV Medication Adherence: A Systematic Review and Synthesis of the Literature', AIDS and behavior, 20(1), pp. 29-50. Available at: https://doi.org/10.1007/s10461-015-1164-1.

    BACKGROUND
  • Chory, A. et al. (2021) 'HIV-Related Knowledge, Attitudes, Behaviors and Experiences of Kenyan Adolescents Living with HIV Revealed in WhatsApp Group Chats', https://doi.org/10.1177/2325958221999579, 20. Available at: https://doi.org/10.1177/2325958221999579.

    BACKGROUND
  • Gesesew (2017) 'Significant association between perceived HIV related stigma and late presentation for HIV/AIDS care in low and middle-income countries: A systematic review and meta-analysis', PLOS ONE, 12(3), p. e0173928. Available at: https://doi.org/10.1371/journal.pone.0173928.

    BACKGROUND
  • Stangl, A.L. et al. (2013) 'A systematic review of interventions to reduce HIV-related stigma and discrimination from 2002 to 2013: how far have we come?', Journal of the International AIDS Society, 16(3 Suppl 2), pp. 18734-18734. Available at: https://doi.org/10.7448/IAS.16.3.18734.

    BACKGROUND

Central Study Contacts

Melkamu Merid Mengesha, Master of Public Health in Epi

CONTACT

Cecilia Follin, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study has two arms, one receiving the digital peer-support based anti-HIV stigma intervention versus the control group receiving the standard an in-clinic in-person based peer support based psychosocial support. Participants were not randomized to the intervention or control groups. Study sites, public hospitals providing an in-clinic psychosocial support to adolescents living with HIV, were purposively selected as control and intervention sites, and consequently, all participants from a selected intervention facility will receive the intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2025

First Posted

February 23, 2026

Study Start

November 13, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Data collected in this study include sensitive individual information and hence the research team do not have the right to share individual patient data.

Locations