Integrating Project YES! With WHO-Endorsed Mental Health Approaches Among Youth Living With HIV

NCT07221201 | Recruiting

• 2 other identifiers: IRB000245975R01TW012411-03
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will address the intersecting stigmas of HIV, violence and depression among adolescents and young adults (15-24) living with HIV (AYALHIV) in Zambia. The study will integrate a WHO-endorsed mental health approach into an existing HIV-stigma-reducing intervention, and refine measures of internalized and intersecting stigmas, to create and test the feasibility of Project YES+- a combined youth peer mentoring and lay mental health intervention. This research aims to shift HIV care and treatment for AYALHIV by addressing the multiple internalized and intersecting stigmas that impeded antiretroviral adherence and HIV viral suppression.

Conditions

HIV - Human Immunodeficiency Virus; Mental Health; Anxiety; Depression in Adolescence; Stigma

Keywords

HIV; Adolescents; Caregivers; Africa; Youth; Intervention

Outcome Measures

Primary Outcomes (3)

• Feasibility of intervention as assessed by percentage of sessions attended

  Feasibility of 90% of AYAHLIV attending at least 80% of the intervention sessions with a 90% confidence interval and a margin of error + 10.

  Up to 4 months

• Number of intervention participants who report they would recommend Project YES+ to their peers

  The endline question is "Overall, you would recommend/not recommend this program to another youth living with HIV" with the response options would recommend, would not recomment, decline to answer"

  up to 4 months

• Number of intervention participants who would recommend Project YES+ for caregivers

  This outcome will be assessed during endline with the question "Overall, you would recommend/not recommend this program to a caregiver of a another youth living with HIV"

  up to four months

Secondary Outcomes (1)

• Number of youth participants with a positive composite score consisting of psychological distress (Kessler 6) and one positive stigma score (internalized, violence, mental health and intersectional stigma).

  Baseline up to approximately 4 months

Study Arms (2)

Standard of Care

NO INTERVENTION

The comparison group will receive the standard of care. Standard of care at ADCH includes an optional monthly AYALHIV youth group. The comparison arm participants will also be offered referrals to health care providers if they screen positive for depression or have experienced severe forms of violence (a process the investigators utilized and refined during the Project YES! study).

Project YES+ intervention arm

EXPERIMENTAL

Project YES+ will be about 4 months and will consist of an orientation meeting with the youth client, their caregiver, the healthcare worker and the youth peer mentor to introduce the intervention. Youth clients will then meet with their YPM individually and in groups with other youth living with HIV in the intervention, and go through the WHO- Self Help plus group meetings. Caregivers will also attend three different caregiver group meetings. At the end, there will be a transition group meeting with youth and caregivers together, followed by one last individual mentoring meeting with the youth. All individual and group meetings are facilitated by the youth peer mentor. Study team members will provide reminder calls for youth and their caregivers before intervention meetings and data collection points.

Behavioral: Project YES+ intervention arm

Interventions

Project YES+ intervention arm BEHAVIORAL

Project YES+ integrates Project YES!

Project YES+ intervention arm

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• For youth
• Be between ages 15-21
• living within 30-minutes, by personal transportation, of the clinic by self-report,
• and being available to attend sessions and data collection over a 4-8 month time period On ART for at least 6 months
• On first-line ART
• Speaks Bemba
• For caregivers
• Being 25 years of age or older
• Caring for an AYALHIV who meets the study eligibility criteria
• Speaks Bemba
• Living within 30-minutes, by personal transportation, of the clinic by self-report
• Being available to attend sessions and data collection over a 4-8 month time period

You may not qualify if:

• For youth,
• only one youth per household may join.
• Also participants will be excluded from joining the RCT if they are at imminent risk of suicide based on WHO guidance on the Self Help plus program.

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Fogarty International Center of the National Institute of Health: collaborator
• Arthur Davison Children's Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Arthur Davison Children's Hospital

Ndola, Copperbelt, Zambia

RECRUITING

Related Publications (26)

• Rahman A, Hamdani SU, Awan NR, Bryant RA, Dawson KS, Khan MF, Azeemi MM, Akhtar P, Nazir H, Chiumento A, Sijbrandij M, Wang D, Farooq S, van Ommeren M. Effect of a Multicomponent Behavioral Intervention in Adults Impaired by Psychological Distress in a Conflict-Affected Area of Pakistan: A Randomized Clinical Trial. JAMA. 2016 Dec 27;316(24):2609-2617. doi: 10.1001/jama.2016.17165.

  PMID: 27837602 BACKGROUND

• Bryant RA, Schafer A, Dawson KS, Anjuri D, Mulili C, Ndogoni L, Koyiet P, Sijbrandij M, Ulate J, Harper Shehadeh M, Hadzi-Pavlovic D, van Ommeren M. Effectiveness of a brief behavioural intervention on psychological distress among women with a history of gender-based violence in urban Kenya: A randomised clinical trial. PLoS Med. 2017 Aug 15;14(8):e1002371. doi: 10.1371/journal.pmed.1002371. eCollection 2017 Aug.

  PMID: 28809935 BACKGROUND

• Dawson KS, Watts S, Carswell K, Shehadeh MH, Jordans MJD, Bryant RA, Miller KE, Malik A, Brown FL, Servili C, van Ommeren M. Improving access to evidence-based interventions for young adolescents: Early Adolescent Skills for Emotions (EASE). World Psychiatry. 2019 Feb;18(1):105-107. doi: 10.1002/wps.20594. No abstract available.

  PMID: 30600639 BACKGROUND

• Epping-Jordan JE, Harris R, Brown FL, Carswell K, Foley C, Garcia-Moreno C, Kogan C, van Ommeren M. Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry. 2016 Oct;15(3):295-296. doi: 10.1002/wps.20355. No abstract available.

  PMID: 27717271 BACKGROUND

• Merrill KG, Campbell JC, Decker MR, McGready J, Burke VM, Mwansa JK, Miti S, Frimpong C, Kennedy CE, Denison JA. Prevalence of physical and sexual violence and psychological abuse among adolescents and young adults living with HIV in Zambia. PLoS One. 2020 Jun 25;15(6):e0235203. doi: 10.1371/journal.pone.0235203. eCollection 2020.

  PMID: 32584889 BACKGROUND

• Ayano G, Demelash S, Abraha M, Tsegay L. The prevalence of depression among adolescent with HIV/AIDS: a systematic review and meta-analysis. AIDS Res Ther. 2021 Apr 27;18(1):23. doi: 10.1186/s12981-021-00351-1.

  PMID: 33906698 BACKGROUND

• Dow DE, Turner EL, Shayo AM, Mmbaga B, Cunningham CK, O'Donnell K. Evaluating mental health difficulties and associated outcomes among HIV-positive adolescents in Tanzania. AIDS Care. 2016 Jul;28(7):825-33. doi: 10.1080/09540121.2016.1139043. Epub 2016 Feb 3.

  PMID: 26837437 BACKGROUND

• Boyes ME, Pantelic M, Casale M, Toska E, Newnham E, Cluver LD. Prospective associations between bullying victimisation, internalised stigma, and mental health in South African adolescents living with HIV. J Affect Disord. 2020 Nov 1;276:418-423. doi: 10.1016/j.jad.2020.07.101. Epub 2020 Jul 20.

  PMID: 32871672 BACKGROUND

• Pantelic M, Shenderovich Y, Cluver L, Boyes M. Predictors of internalised HIV-related stigma: a systematic review of studies in sub-Saharan Africa. Health Psychol Rev. 2015;9(4):469-90. doi: 10.1080/17437199.2014.996243. Epub 2015 Apr 21.

  PMID: 25559431 BACKGROUND

• Pantelic M, Boyes M, Cluver L, Thabeng M. 'They Say HIV is a Punishment from God or from Ancestors': Cross-Cultural Adaptation and Psychometric Assessment of an HIV Stigma Scale for South African Adolescents Living with HIV (ALHIV-SS). Child Indic Res. 2018;11(1):207-223. doi: 10.1007/s12187-016-9428-5. Epub 2016 Nov 23.

  PMID: 29497463 BACKGROUND

• Earnshaw VA, Kidman RC, Violari A. Stigma, Depression, and Substance Use Problems Among Perinatally HIV-Infected Youth in South Africa. AIDS Behav. 2018 Dec;22(12):3892-3896. doi: 10.1007/s10461-018-2201-7.

  PMID: 29909588 BACKGROUND

• Pantelic M, Boyes M, Cluver L, Meinck F. HIV, violence, blame and shame: pathways of risk to internalized HIV stigma among South African adolescents living with HIV. J Int AIDS Soc. 2017 Aug 21;20(1):21771. doi: 10.7448/IAS.20.1.21771.

  PMID: 28853517 BACKGROUND

• Merrill KG, Campbell JC, Decker MR, McGready J, Burke VM, Mwansa JK, Miti S, Frimpong C, Kennedy CE, Denison JA. Past-Year Violence Victimization is Associated with Viral Load Failure Among HIV-Positive Adolescents and Young Adults. AIDS Behav. 2021 May;25(5):1373-1383. doi: 10.1007/s10461-020-02958-3.

  PMID: 32761474 BACKGROUND

• Rongkavilit C, Wang B, Naar-King S, Bunupuradah T, Parsons JT, Panthong A, Koken JA, Saengcharnchai P, Phanuphak P. Motivational interviewing targeting risky sex in HIV-positive young Thai men who have sex with men. Arch Sex Behav. 2015 Feb;44(2):329-40. doi: 10.1007/s10508-014-0274-6. Epub 2014 Mar 26.

  PMID: 24668304 BACKGROUND

• Pantelic M, Steinert JI, Park J, Mellors S, Murau F. 'Management of a spoiled identity': systematic review of interventions to address self-stigma among people living with and affected by HIV. BMJ Glob Health. 2019 Mar 19;4(2):e001285. doi: 10.1136/bmjgh-2018-001285. eCollection 2019.

  PMID: 30997170 BACKGROUND

• Denison JA, Burke VM, Miti S, Nonyane BAS, Frimpong C, Merrill KG, Abrams EA, Mwansa JK. Project YES! Youth Engaging for Success: A randomized controlled trial assessing the impact of a clinic-based peer mentoring program on viral suppression, adherence and internalized stigma among HIV-positive youth (15-24 years) in Ndola, Zambia. PLoS One. 2020 Apr 2;15(4):e0230703. doi: 10.1371/journal.pone.0230703. eCollection 2020.

  PMID: 32240186 BACKGROUND

• Andersson 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.

  PMID: 31776098 BACKGROUND

• Kalichman S, Mathews C, El-Krab R, Banas E, Kalichman M. Forgoing antiretroviral therapy to evade stigma among people living with HIV, Cape Town, South Africa. J Behav Med. 2021 Oct;44(5):653-661. doi: 10.1007/s10865-021-00212-2. Epub 2021 Mar 31.

  PMID: 33788070 BACKGROUND

• Sileo KM, Wanyenze RK, Mukasa B, Musoke W, Kiene SM. The Intersection of Inequitable Gender Norm Endorsement and HIV Stigma: Implications for HIV Care Engagement for Men in Ugandan Fishing Communities. AIDS Behav. 2021 Sep;25(9):2863-2874. doi: 10.1007/s10461-021-03176-1. Epub 2021 Feb 10.

  PMID: 33566214 BACKGROUND

• Hargreaves JR, Pliakas T, Hoddinott G, Mainga T, Mubekapi-Musadaidzwa C, Donnell D, Piwowar-Manning E, Agyei Y, Mandla NF, Dunbar R, Macleod D, Floyd S, Bock P, Fidler S, Hayes RJ, Seeley J, Stangl A, Bond V, Ayles H; HPTN 071 (PopART) Study Team. HIV Stigma and Viral Suppression Among People Living With HIV in the Context of Universal Test and Treat: Analysis of Data From the HPTN 071 (PopART) Trial in Zambia and South Africa. J Acquir Immune Defic Syndr. 2020 Dec 15;85(5):561-570. doi: 10.1097/QAI.0000000000002504.

  PMID: 32991336 BACKGROUND

• Greenwood GL, Wilson A, Bansal GP, Barnhart C, Barr E, Berzon R, Boyce CA, Elwood W, Gamble-George J, Glenshaw M, Henry R, Iida H, Jenkins RA, Lee S, Malekzadeh A, Morris K, Perrin P, Rice E, Sufian M, Weatherspoon D, Whitaker M, Williams M, Zwerski S, Gaist P. HIV-Related Stigma Research as a Priority at the National Institutes of Health. AIDS Behav. 2022 Jan;26(Suppl 1):5-26. doi: 10.1007/s10461-021-03260-6. Epub 2021 Apr 22.

  PMID: 33886010 BACKGROUND

• Scheim AI, Bauer GR. The Intersectional Discrimination Index: Development and validation of measures of self-reported enacted and anticipated discrimination for intercategorical analysis. Soc Sci Med. 2019 Apr;226:225-235. doi: 10.1016/j.socscimed.2018.12.016. Epub 2019 Jan 21.

  PMID: 30674436 BACKGROUND

• Fox AB, Earnshaw VA, Taverna EC, Vogt D. Conceptualizing and Measuring Mental Illness Stigma: The Mental Illness Stigma Framework and Critical Review of Measures. Stigma Health. 2018 Nov;3(4):348-376. doi: 10.1037/sah0000104. Epub 2017 Sep 21.

  PMID: 30505939 BACKGROUND

• Earnshaw VA, Chaudoir SR. From conceptualizing to measuring HIV stigma: a review of HIV stigma mechanism measures. AIDS Behav. 2009 Dec;13(6):1160-77. doi: 10.1007/s10461-009-9593-3. Epub 2009 Jul 28.

  PMID: 19636699 BACKGROUND

• Parker R, Aggleton P. HIV and AIDS-related stigma and discrimination: a conceptual framework and implications for action. Soc Sci Med. 2003 Jul;57(1):13-24. doi: 10.1016/s0277-9536(02)00304-0.

  PMID: 12753813 BACKGROUND

• 4. Goffman E. Stigma: Notes on the management of spoiled identity: Simon and Schuster; 2009

  BACKGROUND

Related Links

• Reference 1
• Reference 2
• Reference 3
• Reference 27

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Psychological Well-Being; Anxiety Disorders; Social Stigma

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Personal Satisfaction; Behavior; Mental Disorders; Social Behavior

Study Officials

• Julie A Denison, PhD

  JHBSPH

  PRINCIPAL INVESTIGATOR

• Sam Miti, BSc HB, MBcHB, MeMMed-PEDS

  Arthur Davison Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Julie A Denison, PhD

CONTACT

13012838643; jdenison@jhu.edu

Kayayi Chibesa, MPH

CONTACT

+260 96 2224671; kayayir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial (Individual Level)

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 27, 2025
• Study Start: October 25, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Once the data is de-identified it may be shared in a repository.
• Access Criteria: The team plans to place the data in an open access repository.

Locations

ZA (1)