PHOLA - Promoting Holistic Outcomes in the Lives of Adolescents

Adaptation and feasibility of WHO PM+ for adolescents living with HIV in KwaZulu- Natal Province, South Africa

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202506882906938

Enrollment

Registered

2025-06-27

Start date

2026-01-12

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS Mental and Behavioural Disorders

Interventions

Problem Management Plus Adherence

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adolescents will be included in the study if they are aged 16–19 at the time of recruitment Reside in uMkhanyakude at the time of recruitment Have a score of =5 on the Patient Health Questionnaire (PHQ-9) or Generalised Anxiety Disorder Scale (GAD-7) Provide written informed consent

Exclusion criteria

Exclusion criteria: Individuals with a self-reported history of severe mental illness, including psychotic-related disorders, bipolar disorders, eating disorders and substance dependence Individuals with cognitive deficits (assessed using the Mini-Mental Status Examination) Those presenting with suicidal ideation or judged to be at active risk of suicide (as assessed using the Columbia- Suicide Severity Rating Scale) Individuals undergoing active psychiatric treatment (i.e., on psychotropic medication or receiving formal psychotherapy)

Design outcomes

Primary

Measure	Time frame
(1)Reach - how many of the approached ALHIV are enrolled in the study (2)Adoption and retention - the number of enrolled participants who attend =50% of sessions and undergo the final assessment at 6 months; (3)Acceptability of the co-adapted intervention to determine how well the target population will receive the adapted intervention, the extent to which the intervention components meet the needs of the target population and the setting and (4)Implementation - assess fidelity to the various elements of the intervention’s protocol, including consistency of delivery as intended as well as the adolescents’ use of the intervention strategies	—

Measure

Time frame

(1)Reach - how many of the approached ALHIV are enrolled in the study (2)Adoption and retention - the number of enrolled participants who attend =50% of sessions and undergo the final assessment at 6 months; (3)Acceptability of the co-adapted intervention to determine how well the target population will receive the adapted intervention, the extent to which the intervention components meet the needs of the target population and the setting and (4)Implementation - assess fidelity to the various elements of the intervention’s protocol, including consistency of delivery as intended as well as the adolescents’ use of the intervention strategies

—

Secondary

Measure	Time frame
HIV-related: viral suppression and adherence Mental health and well-being: the Depression (PHQ-9), Anxiety (GAD-7), Sleep (Patient-Reported Outcomes Information System Sleep Disturbance Scale), Resilience (Child and Youth Resilience Measure), Well-being (Personal Well-Being Score)	—

Countries

South Africa

Contacts

Public ContactNduku Wambua

Africa Health Research Institute

nduku.wambua@ahri.org+27352510788

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026