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NCT Number: NCT03704805

Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe

The aim of the study is to examine the effect of a psychological intervention on antiretroviral therapy outcomes and symptoms of common mental health disorders among adults living with HIV and common mental disorders in rural Zimbabwe.

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Key information

Conditions

Mental Disorder Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solidarmed

Masvingo, Zimbabwe

About this study

Common mental disorders are highly prevalent among people living with HIV. Left untreated, common mental disorders cause substantial disability and undermine individuals' ability to adhere to antiretroviral therapy, leading to poor antiretroviral therapy outcomes.

A recent cluster-randomized controlled trial from Harare, Zimbabwe showed that the friendship bench intervention (i.e. six sessions of problem-solving therapy delivered by lay health workers followed by a peer support group) effectively reduced symptoms of common mental disorders, but the effect of the intervention on antiretroviral therapy outcomes and its effectiveness in the rural setting has not been studied.

To examine the effect of the friendship bench intervention on antiretroviral therapy outcomes and symptoms of common mental disorders among adults living with HIV and common mental disorders in rural Zimbabwe, a cluster-randomized trial is conducted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Use of first-line antiretroviral therapy for at least 6 months
  • Resident in Bikita District
  • Knowledge of English or Shona language
  • Ability to comprehend the information on the study
  • Positive screening for common mental disorders (SSQ-14 score ≥9)
  • Providing informed consent

Exclusion criteria

  • Current psychosis / cognitive impairment
  • Clinical AIDS (WHO clinical stage 4)
  • Known pregnancy or ≤3 months postpartum

Treatment and study plan

Friendship bench intervention

Behavioral

The friendship bench intervention consists of six individual counseling sessions and a peer-led group activity. Individual counseling is based on problem-solving therapy and delivered by lay health workers. During individual counseling, participants will be actively encouraged to identify and tackle problems leading to sub-optimal antiretroviral therapy adherence. In the group activity, participants are taught an income generating skill and have the opportunity to share personal experience with former participants of the intervention.

Enhanced Standard of Care

Other

Study participants receive information on available routine services for common mental disorders, a nurse-led brief support counseling, assessment for antidepressant medication (fluoxetine) by the clinic nurse, and referral to a psychiatric facility if needed, in addition to the standard of care provided according to national antiretroviral therapy guidelines.

Primary outcomes

  1. Average difference in mean antiretroviral therapy adherence between 2 and 6 months

    Time frame: 2-6 months

    Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)

Secondary outcomes

  1. Difference in mean antiretroviral therapy adherence between 1 and 12 months

    Time frame: 1-12 months

    Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)

  2. Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score

    Time frame: At month 3, 6, 9, and 12

    The Shone Symptoms Questionnaire is a 14 item tool. The reported total score is between 0 and 14. 14 is the highest level of mental disorder. Each item adds a score of 0 or 1 to the total score.

  3. Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score

    Time frame: At month 3, 6, 9, and 12

    The Patient Health Questionnaire is a 9 item tool. The reported total score is between 0 and 27. 27 is the highest level of depression. Each item adds a score of 0 to 3 to the total score.

  4. Viral load suppression (<1000 copies per milliliter)

    Time frame: At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days)

    Categorical (yes, no, invalid or missing).

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • SolidarMed

Registry information

Official study title

Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Oct 15, 2018
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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