NCT05482217

Brief Summary

Aim: To explore the effectiveness of psychoeducation and problem-solving (Life-steps) on depression and adherence in HIV-infected adolescents. Methods: Forty-two adolescents were randomized into 21 controls and 21 intervention groups. The intervention group was exposed to 5-week sessions of life steps applied by a lay counselor. The PHQ-9 and visual analog scale (VAS) were used to measure the outcomes: depression and adherence. They were applied at baseline, 5-weeks, and 24 weeks post-intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 2, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2022

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 1, 2022

Completed
Last Updated

August 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 12, 2022

Last Update Submit

July 28, 2022

Conditions

Medication NonadherenceDepressionHIV Infections

Keywords

psychoeducationproblem-solvingdepressionLife-stepsHIV-infected adolescentsclinical trial

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms were measured with Patient Health Questionnaire (PHQ-9), has sensitivity and specificity of 0.8 and 0.7. The cut-off of nine or more was consistent with a diagnosis of depression

    Change in PHQ-9 score or change in depressive symptoms score

    5 weeks

Secondary Outcomes (1)

  • Medication adherence: measured with the Visual Analogue Scale (VAS), a horizontal line, 10cm long, and calibrated by 5 from 0 to 100. Score of <95% is suboptimal adherence based on 30 days pill use. It exhibits medium to large strength (r = 0.5-0.7).

    5 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

This group was exposed to psychoeducational and problem-solving sessions for five weeks.

Behavioral: Psychoeducation, problem solving and rehearsal (cognitive behavioural intervention)

The control group

NO INTERVENTION

No intervention was given: only the regular clinic advice for five weeks or treatment as usual.

Interventions

Psychoeducation, problem solving and rehearsal (cognitive behavioural intervention)BEHAVIORAL

The highlights of the intervention. Session 1: Rapport building and knowledge of HIV Session 2: Identifying and Dealing with barriers to good adherence Session 3: Identifying and dealing with problems in relation to depression and adherence: Session 4: Identifying and dealing with negative cognitions, handling privacy, accessing social Support, and adjusting to HIV and antiretroviral treatment Session 5: Rehearsal of practical tips on adherence, handling slips, and strategies to improve quality of life. All sessions involved brief periods of relaxation, homework, and a homework review. The last session was concluded with the assessment of satisfaction with the program. The programs were conducted for 60 minutes weekly for five weeks. They were delivered by a trained lay counselor and supervised by the principal investigator for five weeks.

Also known as: Cognitive behavioural intervention (CBI)
Intervention group

Eligibility Criteria

Age12 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • HIV infected adolescents aged, 12 - 19 years
  • On ART for a minimum of six months.
  • Speak or communicate in Setswana or English.
  • Outpatient
  • Willing to participate

You may not qualify if:

  • Psychotic, and intellectually disabled patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor children's clinical center of excellence

Gaborone, Botswana

Location

Related Publications (1)

  • Olashore AA, Paruk S, Ogunwale A, Ita M, Tomita A, Chiliza B. The effectiveness of psychoeducation and problem-solving on depression and treatment adherence in adolescents living with HIV in Botswana: an exploratory clinical trial. Child Adolesc Psychiatry Ment Health. 2023 Jan 4;17(1):2. doi: 10.1186/s13034-022-00541-3.

    PMID: 36600262DERIVED

MeSH Terms

Conditions

Medication AdherenceDepressionHIV Infections

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehaviorBehavioral SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2022

First Posted

August 1, 2022

Study Start

July 26, 2021

Primary Completion

November 2, 2021

Study Completion

May 3, 2022

Last Updated

August 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Anonymised data may be shared on request by the publisher

Locations

BO(1)