HIV-related StigmaNCT07425925
Digital Peer-support-based Anti-HIV Stigma Intervention Among Adolescents Living With HIV in Ethiopia
A study testing Peer support based digital anti-HIV stigma intervention and A standard in-clinic in-person psychosocial support in people with HIV-related Stigma and Psychological Wellbeing, run by Lund University at 5 sites in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- HIV-related Stigma, Psychological Wellbeing, Retention in Care
- What is being tested?
- Peer support based digital anti-HIV stigma intervention and A standard in-clinic in-person psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 5 sitesEthiopia
- Study dates
- 13 Nov 2025to 4 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- Participants with known diagnosed mental health condition
- Participants with hearing loss or loss of vision
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Ethiopia5 sites
Arba Minch General Hospital
Arba Minch, South Ethiopia
Dilla University Teaching Hospital
Dara, South Ethiopia
Sawula General Hospital
Gofa, South Ethiopia
Jinka General Hospital
Jinka, South Ethiopia
Wolaita Sodo University Comprehensive Specialized Hospital and Sodo Health Center
Sodo, South Ethiopia
About this study
Official title: Feasibility and Effectiveness of Digital Peer-support-based Anti-HIV Stigma Intervention in Improving Clinical Outcomes Among Adolescents Living With HIV in Ethiopia
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.
Read the detailed description
Introduction The advent of the antiretroviral therapy (ART) and its widespread use have turned HIV/AIDS, a condition once considered as a death sentence, into a chronic disease with perinatally HIV infected children are now living longer and transition into adulthood. Despite this clinical success story, psychological wellbeing of adolescents is overlooked, mainly due to HIV-related stigma, as interventions to reduce stigma did not often target children.
Stigma and discrimination related to HIV infection inhibit health-seeking behavior, clinical outcomes, physical and psychosocial wellbeing and is a major obstacle for timely diagnosis and linkage to care, including adherence to antiretroviral therapy. As a counter to negative experiences, peer-support group by people living with HIV improved self-confidence of members and consequently reduced self-stigma and improved their coping ability against external stigma.
The eHealth, which comprise a range of information and communication resources and tools including text messaging, videos and social media, is uniquely positioned to share interactive health information pseudonymously. However, there is a lack of digital peer-support group interventions for adolescents with a focus on HIV stigma reduction. While different eHealth services provide social support and have the potential to target interventions delivered in the traditional methods, only a few have used it, mostly for ART adherence interventions.
A recent review of stigma reduction interventions in people living with HIV reported a lack of well-designed intervention studies investigating stigma reduction to wither the challenge of HIV-related stigma in HIV care and support. Thus, there is a need for anti-stigma interventions and the effect on health-related outcomes among adolescents living with HIV.
The in-person in-clinic psychosocial peer-support is widely implemented, but this important program had shortfalls with operational logistics. The program, for example, has been severely interrupted during the high picks of covid-19 restrictions, there were also issues of accessibility and the need to travel long distance, unintended disclosure, and funding availability to run programs.
A recent systematic review identified that adolescents and caregivers identified psychosocial needs as their priority where stigma and HIV status disclosure were the most reported challenges. Despite effective anti-stigma interventions are reported among adults living with HIV, there is limited evidence of effective anti-stigma interventions among adolescents living with HIV. The intervention approaches used in previous interventions include information-based approaches, skills building, counselling/support groups, and contact with affected groups. Most interventions, however, used more than one approach though 81% targeted a single domain of stigma and 85% targeted a single socio-ecologic level.
Using a digital peer support-based intervention, the present study will bridge the gaps in previous studies by targeting more than one stigma mechanism and ecological levels and by assessing the impact of anti-HIV stigma interventions. The present study will investigate whether the digital peer-support anti-HIV stigma reduces internalized and anticipated stigma among 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.
Objective Evaluate the effect of digital peer-support-based intervention on anticipated- and internalized HIV-stigma, psychological wellbeing, and retention in care among adolescents and youth living with HIV.
Methods We follow the MRC framework for complex intervention as methodologic guide, and to evaluate the intervention, we will conduct a quasi-experimental study for the duration of 16 weeks. Validated tools tested in Ethiopian context in the project will be used to measure the primary outcome, internalized- and anticipated-HIV-related stigma. The twelve item short version of the Berger HIV-related stigma scale, the HIV stigma scale-12 (HSS-12), will be used to measure HIV-related stigma. The scale has a Likert scale response options, 1 "Strongly disagree" to 4"Strongly agree". The possible score range for the total HSS-12 scale will be 12 to 48. Higher values indicate a higher level of stigma. The secondary outcomes include psychological wellbeing, mainly depression and anxiety, and retention in care. The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression and the Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Both PHQ-9 and GAD-7 have response options in Likert scale ranging from 0"never at all" to 3"almost always". For the PHQ-9, possible score range is 0 to 27, and for the GAD-7, it is 0 to 21, where higher values indicate a worse outcome. Retention in care will be measured based on proportion of kept visits from a total scheduled visits during the past 12-months preceding the assessment period. A linear mixed model will be used to estimate effect of the intervention on psychological and/or clinical outcomes; a structured equation modelling will be used to designate possible causal pathways for the outcomes of interest.
- Being tested
- Peer support based digital anti-HIV stigma intervention, A standard in-clinic in-person psychosocial support
- Keywords
- digital peer-support, HIV-related stigma, adolescents living with HIV, south Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer support based digital anti-HIV stigma interventionBehavioural
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.
A standard in-clinic in-person psychosocial supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer support based digital anti-HIV stigma intervention; Behavioral: 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. Receives: Behavioral: A standard in-clinic in-person psychosocial support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment at baseline to the end of intervention at 16 weeks.
Secondary outcomes (2)
Psychological well-being
- 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.
Measured: From enrollment at baseline to the end of intervention at 16 weeks.
Retention in care
- 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.
Measured: From enrollment at baseline to the end of intervention at 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start13 Nov 2025
- Primary completion20 Jun 2026
- Study completion4 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for HIV-related StigmaStudies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07425925
- Sponsor's protocol ID
- Dnr 2023-04045-01
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected in this study include sensitive individual information and hence the research team do not have the right to share individual patient data.
Publications
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.
PubMed 30967483Spitzer 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.
PubMed 16717171Kane JC, Elafros MA, Murray SM, Mitchell EMH, Augustinavicius JL, Causevic S, Baral SD. A scoping review of health-related stigma outcomes for high-burden diseases in low- and middle-income countries. BMC Med. 2019 Feb 15;17(1):17. doi: 10.1186/s12916-019-1250-8.
PubMed 30764819Dyer J, Wilson K, Badia J, Agot K, Neary J, Njuguna I, Kibugi J, Healy E, Beima-Sofie K, John-Stewart G, Kohler P. The Psychosocial Effects of the COVID-19 Pandemic on Youth Living with HIV in Western Kenya. AIDS Behav. 2021 Jan;25(1):68-72. doi: 10.1007/s10461-020-03005-x.
PubMed 32816193Chem ED, Ferry A, Seeley J, Weiss HA, Simms V. Health-related needs reported by adolescents living with HIV and receiving antiretroviral therapy in sub-Saharan Africa: a systematic literature review. J Int AIDS Soc. 2022 Aug;25(8):e25921. doi: 10.1002/jia2.25921.
PubMed 35983685Mark D, Hrapcak S, Ameyan W, Lovich R, Ronan A, Schmitz K, Hatane L. Peer Support for Adolescents and Young People Living with HIV in sub-Saharan Africa: Emerging Insights and a Methodological Agenda. Curr HIV/AIDS Rep. 2019 Dec;16(6):467-474. doi: 10.1007/s11904-019-00470-5.
PubMed 31776974Biru M, Lunqvist P, Molla M, Jerene D, Hallstrom I. 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. Compr Child Adolesc Nurs. 2018 Dec;41(4):293-309. doi: 10.1080/24694193.2017.1372531. Epub 2017 Dec 8.
PubMed 29220598Andersson GZ, Reinius M, Eriksson LE, Svedhem V, Esfahani FM, Deuba K, Rao D, Lyatuu GW, Giovenco D, Ekstrom AM. Stigma reduction interventions in people living with HIV to improve health-related quality of life. Lancet HIV. 2020 Feb;7(2):e129-e140. doi: 10.1016/S2352-3018(19)30343-1. Epub 2019 Nov 24.
PubMed 31776098Rao D, Frey S, Ramaiya M. eHealth for Stigma Reduction Efforts Designed to Improve Engagement in Care for People Living with HIV. Curr HIV/AIDS Rep. 2018 Dec;15(6):397-402. doi: 10.1007/s11904-018-0414-z.
PubMed 30232579Simpson N, Kydd A, Phiri M, Mbewe M, Sigande L, Gachie T, Ngobeni M, Monese T, Figerova Z, Schlesinger H, Bond V, Belemu S, Simwinga M, Schaap A, Biriotti M, Fidler S, Ayles H. Insaka: mobile phone support groups for adolescent pregnant women living with HIV. BMC Pregnancy Childbirth. 2021 Sep 30;21(1):663. doi: 10.1186/s12884-021-04140-6.
PubMed 34592959Mburu G, Ram M, Skovdal M, Bitira D, Hodgson I, Mwai GW, Stegling C, Seeley J. Resisting and challenging stigma in Uganda: the role of support groups of people living with HIV. J Int AIDS Soc. 2013 Nov 13;16(3 Suppl 2):18636. doi: 10.7448/IAS.16.3.18636.
PubMed 24242256Sweeney SM, Vanable PA. The Association of HIV-Related Stigma to HIV Medication Adherence: A Systematic Review and Synthesis of the Literature. AIDS Behav. 2016 Jan;20(1):29-50. doi: 10.1007/s10461-015-1164-1.
PubMed 26303196Chory A, Nyandiko W, Martin R, Aluoch J, Scanlon M, Ashimosi C, Njoroge T, McAteer C, Apondi E, Vreeman R. HIV-Related Knowledge, Attitudes, Behaviors and Experiences of Kenyan Adolescents Living with HIV Revealed in WhatsApp Group Chats. J Int Assoc Provid AIDS Care. 2021 Jan-Dec;20:2325958221999579. doi: 10.1177/2325958221999579.
PubMed 33657911Gesesew HA, Tesfay Gebremedhin A, Demissie TD, Kerie MW, Sudhakar M, Mwanri L. 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. 2017 Mar 30;12(3):e0173928. doi: 10.1371/journal.pone.0173928. eCollection 2017.
PubMed 28358828Stangl AL, Lloyd JK, Brady LM, Holland CE, Baral S. A systematic review of interventions to reduce HIV-related stigma and discrimination from 2002 to 2013: how far have we come? J Int AIDS Soc. 2013 Nov 13;16(3 Suppl 2):18734. doi: 10.7448/IAS.16.3.18734.
PubMed 24242268
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of Digital Peer-support-based Anti-HIV Stigma Intervention in Improving Clinical Outcomes Among Adolescents Living With HIV in Ethiopia
- ClinicalTrials.gov ID
- NCT07425925
- Acronym / sponsor ID
- Dnr 2023-04045-01
- Keywords
- digital peer-support, HIV-related stigma, adolescents living with HIV, south Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- 13 Nov 2025 (actual)
- Primary completion
- 20 Jun 2026 (actual)
- Study completion
- 4 Aug 2026 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction The advent of the antiretroviral therapy (ART) and its widespread use have turned HIV/AIDS, a condition once considered as a death sentence, into a chronic disease with perinatally HIV infected children are now living longer and transition into adulthood. Despite this clinical success story, psychological wellbeing of adolescents is overlooked, mainly due to HIV-related stigma, as interventions to reduce stigma did not often target children.
Stigma and discrimination related to HIV infection inhibit health-seeking behavior, clinical outcomes, physical and psychosocial wellbeing and is a major obstacle for timely diagnosis and linkage to care, including adherence to antiretroviral therapy. As a counter to negative experiences, peer-support group by people living with HIV improved self-confidence of members and consequently reduced self-stigma and improved their coping ability against external stigma.
The eHealth, which comprise a range of information and communication resources and tools including text messaging, videos and social media, is uniquely positioned to share interactive health information pseudonymously. However, there is a lack of digital peer-support group interventions for adolescents with a focus on HIV stigma reduction. While different eHealth services provide social support and have the potential to target interventions delivered in the traditional methods, only a few have used it, mostly for ART adherence interventions.
A recent review of stigma reduction interventions in people living with HIV reported a lack of well-designed intervention studies investigating stigma reduction to wither the challenge of HIV-related stigma in HIV care and support. Thus, there is a need for anti-stigma interventions and the effect on health-related outcomes among adolescents living with HIV.
The in-person in-clinic psychosocial peer-support is widely implemented, but this important program had shortfalls with operational logistics. The program, for example, has been severely interrupted during the high picks of covid-19 restrictions, there were also issues of accessibility and the need to travel long distance, unintended disclosure, and funding availability to run programs.
A recent systematic review identified that adolescents and caregivers identified psychosocial needs as their priority where stigma and HIV status disclosure were the most reported challenges. Despite effective anti-stigma interventions are reported among adults living with HIV, there is limited evidence of effective anti-stigma interventions among adolescents living with HIV. The intervention approaches used in previous interventions include information-based approaches, skills building, counselling/support groups, and contact with affected groups. Most interventions, however, used more than one approach though 81% targeted a single domain of stigma and 85% targeted a single socio-ecologic level.
Using a digital peer support-based intervention, the present study will bridge the gaps in previous studies by targeting more than one stigma mechanism and ecological levels and by assessing the impact of anti-HIV stigma interventions. The present study will investigate whether the digital peer-support anti-HIV stigma reduces internalized and anticipated stigma among 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.
Objective Evaluate the effect of digital peer-support-based intervention on anticipated- and internalized HIV-stigma, psychological wellbeing, and retention in care among adolescents and youth living with HIV.
Methods We follow the MRC framework for complex intervention as methodologic guide, and to evaluate the intervention, we will conduct a quasi-experimental study for the duration of 16 weeks. Validated tools tested in Ethiopian context in the project will be used to measure the primary outcome, internalized- and anticipated-HIV-related stigma. The twelve item short version of the Berger HIV-related stigma scale, the HIV stigma scale-12 (HSS-12), will be used to measure HIV-related stigma. The scale has a Likert scale response options, 1 "Strongly disagree" to 4"Strongly agree". The possible score range for the total HSS-12 scale will be 12 to 48. Higher values indicate a higher level of stigma. The secondary outcomes include psychological wellbeing, mainly depression and anxiety, and retention in care. The Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression and the Generalized Anxiety Disorder-7 (GAD-7) will be used to measure anxiety. Both PHQ-9 and GAD-7 have response options in Likert scale ranging from 0"never at all" to 3"almost always". For the PHQ-9, possible score range is 0 to 27, and for the GAD-7, it is 0 to 21, where higher values indicate a worse outcome. Retention in care will be measured based on proportion of kept visits from a total scheduled visits during the past 12-months preceding the assessment period. A linear mixed model will be used to estimate effect of the intervention on psychological and/or clinical outcomes; a structured equation modelling will be used to designate possible causal pathways for the outcomes of interest.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Digital peer support | Experimental | Behavioral: Peer support based digital anti-HIV stigma intervention, Behavioral: A standard in-clinic in-person psychosocial supportIn 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. |
| In-person peer support | Active comparator | Behavioral: A standard in-clinic in-person psychosocial supportIn 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. |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Participants with known diagnosed mental health condition
- Participants with hearing loss or loss of vision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer support based digital anti-HIV stigma interventionParticipants 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. | Behavioural | Digital peer support |
| A standard in-clinic in-person psychosocial supportIn 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. | Behavioural | Digital peer support, In-person peer support |
Primary outcome
HIV-related stigma: internalised and anticipated
Time frame: From enrollment at baseline to the end of intervention at 16 weeks.
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).
2 secondary outcomes
Psychological well-being
Time frame: From enrollment at baseline to the end of intervention at 16 weeks.
Retention in care
Time frame: From enrollment at baseline to the end of intervention at 16 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 30967483Levis 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.
- Background: PubMed 16717171Spitzer 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.
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- Individual participant dataSharing planned: No. Data collected in this study include sensitive individual information and hence the research team do not have the right to share individual patient data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer support based digital anti-HIV stigma intervention and A standard in-clinic in-person psychosocial support in people with HIV-related Stigma and Psychological Wellbeing, run by Lund University at 5 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV-related stigma: internalised and anticipated (time frame: From enrollment at baseline to the end of intervention at 16 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07425925, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.