Mental DisorderNCT03704805
Effect of a Psychological Intervention on Antiretroviral Therapy and Mental Health Outcomes in HIV-positive Adults in Zimbabwe
A study testing Friendship bench intervention in people with Mental Disorder and HIV Infections, run by University of Bern at 1 site in Zimbabwe.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Disorder, HIV Infections
- What is being tested?
- Friendship bench intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteZimbabwe
- Study dates
- 5 Oct 2018to 5 Feb 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current psychosis / cognitive impairment
- Clinical AIDS (WHO clinical stage 4)
- Known pregnancy or ≤3 months postpartum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural 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.
Read the detailed description
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.
- Conditions
- Mental Disorder, HIV Infections
- Being tested
- Friendship bench intervention, Enhanced Standard of Care
- Medical subject headings
- Mental Disorders, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Friendship bench interventionBehavioural
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Problem-Solving Therapy | Experimental | Participants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care. Receives: Behavioral: Friendship bench intervention; Other: Enhanced Standard of Care |
| Enhanced Standard of Care | Active comparator | Participants in the control group receive enhanced standard of care. Receives: Other: Enhanced Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average difference in mean antiretroviral therapy adherence between 2 and 6 months
Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
Measured: 2-6 months
Secondary outcomes (4)
Difference in mean antiretroviral therapy adherence between 1 and 12 months
Adherence will be calculated as percentage of prescribed doses taken and measured with the Medication Event Monitoring System (MEMS)
Measured: 1-12 months
Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score
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.
Measured: At month 3, 6, 9, and 12
Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score
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.
Measured: At month 3, 6, 9, and 12
Viral load suppression (<1000 copies per milliliter)
Categorical (yes, no, invalid or missing).
Measured: At month 6 (i.e., day 180 ± 90 days) and month 12 (i.e., day 360 ± 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start5 Oct 2018
- Primary completion15 Jul 2020
- Study completion5 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mental DisorderStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-randomized, controlled, two-arm multicenter, superiority trial
- Masking
- None (open label)
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Collaborators
- SolidarMed
- Responsible party
- Sponsor
- Investigators
- Andreas D Haas, PhD, Principal investigator, Institute of Social and Preventive Medicine (ISPM), University of BernCordelia Kunzekwenyika, MD, Principal investigator, SolidarMed, Swiss Organisation for Health in Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704805
- Sponsor's protocol ID
- FB-ART
- Status last verified
- Apr 2023
- First submitted
- 10 Oct 2018
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haas AD, Kunzekwenyika C, Manzero J, Hossmann S, Limacher A, van Dijk JH, Manhibi R, von Groote P, Hobbins MA, Verhey R, Egger M; Friendship Bench ART trial group. Effect of the Friendship Bench Intervention on Antiretroviral Therapy Outcomes and Mental Health Symptoms in Rural Zimbabwe: A Cluster Randomized Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2323205. doi: 10.1001/jamanetworkopen.2023.23205.
PubMed 37440230Haas AD, Kunzekwenyika C, Manzero J, Hossmann S, Limacher A, van Dijk JH, Manhibi R, von Groote P, Hobbins MA, Verhey R, Egger M; Friendship Bench ART trial group. Effect of the Friendship Bench intervention on antiretroviral therapy outcomes and mental health symptoms in rural Zimbabwe: A cluster randomized trial. medRxiv [Preprint]. 2023 Jan 22:2023.01.21.23284784. doi: 10.1101/2023.01.21.23284784.
PubMed 36711671Haas AD, Kunzekwenyika C, Hossmann S, Manzero J, van Dijk J, Manhibi R, Verhey R, Limacher A, von Groote PM, Manda E, Hobbins MA, Chibanda D, Egger M; IeDEA Southern Africa. Symptoms of common mental disorders and adherence to antiretroviral therapy among adults living with HIV in rural Zimbabwe: a cross-sectional study. BMJ Open. 2021 Jul 7;11(7):e049824. doi: 10.1136/bmjopen-2021-049824.
PubMed 34233999
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Psychological Intervention on Antiretroviral Therapy Outcomes and Symptoms of Common Mental Disorders in HIV-positive Adults in Rural Zimbabwe
- ClinicalTrials.gov ID
- NCT03704805
- Acronym / sponsor ID
- FB-ART
- Conditions
- Mental Disorder, HIV Infections
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Collaborators
- SolidarMed
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 5 Feb 2021 (actual)
- First posted
- 15 Oct 2018 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster-randomized, controlled, two-arm multicenter, superiority trial
| Arm | Type | Receives |
|---|---|---|
| Problem-Solving Therapy | Experimental | Behavioral: Friendship bench intervention, Other: Enhanced Standard of CareParticipants in the intervention group receive the friendship bench intervention in addition to all services provided according to enhanced standard of care. |
| Enhanced Standard of Care | Active comparator | Other: Enhanced Standard of CareParticipants in the control group receive enhanced standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Current psychosis / cognitive impairment
- Clinical AIDS (WHO clinical stage 4)
- Known pregnancy or ≤3 months postpartum
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 |
|---|---|---|
| Friendship bench interventionThe 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. | Behavioural | Problem-Solving Therapy |
| Enhanced Standard of CareStudy 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. | Other | Enhanced Standard of Care, Problem-Solving Therapy |
Primary outcome
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)
4 secondary outcomes
Difference in mean antiretroviral therapy adherence between 1 and 12 months
Time frame: 1-12 months
Difference in change from baseline in Shona Symptoms Questionnaire (SSQ-14) score
Time frame: At month 3, 6, 9, and 12
Difference in change from baseline in Patient Health Questionnaire (PHQ-9) score
Time frame: At month 3, 6, 9, and 12
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)
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 1 May 2023.
- Derived from this study: PubMed 37440230Haas AD, Kunzekwenyika C, Manzero J, Hossmann S, Limacher A, van Dijk JH, Manhibi R, von Groote P, Hobbins MA, Verhey R, Egger M; Friendship Bench ART trial group. Effect of the Friendship Bench Intervention on Antiretroviral Therapy Outcomes and Mental Health Symptoms in Rural Zimbabwe: A Cluster Randomized Trial. JAMA Netw Open. 2023 Jul 3;6(7):e2323205. doi: 10.1001/jamanetworkopen.2023.23205.
- Derived from this study: PubMed 36711671Haas AD, Kunzekwenyika C, Manzero J, Hossmann S, Limacher A, van Dijk JH, Manhibi R, von Groote P, Hobbins MA, Verhey R, Egger M; Friendship Bench ART trial group. Effect of the Friendship Bench intervention on antiretroviral therapy outcomes and mental health symptoms in rural Zimbabwe: A cluster randomized trial. medRxiv [Preprint]. 2023 Jan 22:2023.01.21.23284784. doi: 10.1101/2023.01.21.23284784.
- Derived from this study: PubMed 34233999Haas AD, Kunzekwenyika C, Hossmann S, Manzero J, van Dijk J, Manhibi R, Verhey R, Limacher A, von Groote PM, Manda E, Hobbins MA, Chibanda D, Egger M; IeDEA Southern Africa. Symptoms of common mental disorders and adherence to antiretroviral therapy among adults living with HIV in rural Zimbabwe: a cross-sectional study. BMJ Open. 2021 Jul 7;11(7):e049824. doi: 10.1136/bmjopen-2021-049824.
- Individual participant dataSharing planned: Undecided
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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.
Andreas D Haas, PhD principal investigator
Institute of Social and Preventive Medicine (ISPM), University of Bern
Cordelia Kunzekwenyika, MD principal investigator
SolidarMed, Swiss Organisation for Health in Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Friendship bench intervention in people with Mental Disorder and HIV Infections, run by University of Bern at 1 site in Zimbabwe.
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 7 inclusion and 3 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zimbabwe. 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?
Average difference in mean antiretroviral therapy adherence between 2 and 6 months (time frame: 2-6 months). 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 NCT03704805, which also lists 3 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 1 May 2023.