Please select the eligibility criteria that correspond to the clinical trial below.
Title: Collaborative Care for the Detection and Management of Depression Among Adults Receiving Antiretroviral Therapy in South Africa: a Pragmatic Cluster Randomized Controlled Trial
Brief Summary: With increasing access to antiretroviral therapy (ART) in South Africa, HIV has transitioned from a terminal illness to a long-term condition. It is likely to be accompanied by higher levels of disability and other chronic non-communicable diseases, resulting from the HIV itself, as well as adverse effects of medication. This requires an expansion of the purview of HIV care beyond direct HIV clinical care to also include a more comprehensive and integrated package of treatment and care for physical and mental conditions and their consequences. COBALT is a pragmatic cluster randomized controlled trial (RCT) in public sector primary care clinics in the North West Province of SA. It will assess mental health and HIV outcomes for depressed adults receiving ART by measuring the real-world effectiveness of a facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.


Options:
A: Inclusion Criteria:

* HIV seropositive pregnant women with partners, 20-24 weeks pregnant (typical time of entry into antenatal clinic care), aged \>18.
* In Phase 2 (couples phase), both women and their partners will be enrolled. For the purposes of this study, primary male partners are defined as 1) husband, 2) current baby's father, or 3) current sexual partner.

Exclusion Criteria:

* Persons actively psychotic (auditory or visual hallucination) or intoxicated (e.g., under the influence of alcohol of illegal drugs) will not be eligible and will be referred for treatment. Following resolution of symptoms, these persons will be eligible for the study. N.B.: Any person presenting for sessions actively psychotic or intoxicated will be referred for treatment and will not be eligible to participate in sessions until symptoms are resolved due to reduced likelihood of benefit from sessions.
B: Inclusion Criteria:

Clinics:

1) 40 nurse-led primary care clinics providing ART in the Dr Kenneth Kaunda and Bojonala districts of the North West Province, South Africa

Patients:

1. Age ≥ 18 years and
2. Receiving ART at the time of enrollment and
3. Depressive symptoms, as indicated by a total score of 9 or more on the PHQ-9 and
4. Planning to reside in the area for the next year and
5. Capable of actively engaging in an interviewer-administered questionnaire at the time of recruitment, six and twelve months later and
6. Written consent to participate in the study

Exclusion Criteria:

Clinics:

1) Clinics which participate in the formative research and piloting of the intervention

Patients:

1) Inability to meet the above inclusion criteria
C: Inclusion criteria for phase 1

* Participant in the ongoing Butajira SMD cohort study (at baseline (between 1998 and 2001), cohort participants were aged between 15 and 49 years, resident in the area for at least six months and had a DSM-IV (SCAN) diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder)
* Ongoing need for continuing mental health care due to:

  1. being on psychotropic medication at assessment or,
  2. not on medication but symptomatic at the time of assessment, or
  3. have experienced partial or full relapse within the two years preceding the assessment
* Stable clinical condition: either in remission from SMD or with residual symptoms that have been stable over the preceding three months.
* Planning to stay resident in the area for 18 months.
* Able to communicate in Amharic, the official language of Ethiopia.
* Willing to be randomised to either of the service models as described in the protocol.
* Has capacity to consent to participation or permission given by guardian and not refusing to participate
* Resident in catchment area of TaSCS health centres (excluding Butajira health centre)

Exclusion criteria for phase 1

* Suicide attempt within the preceding three months
* Current active suicide intent
* Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine), as these medications are not be available in psychiatric nurse-led units or PHC settings in Ethiopia. Within the Butajira SMD cohort, only people who have received care from psychiatrist-led units in the capital city, Addis Ababa, might be receiving these medications. At present, fewer than 10 patients are known to be taking one of these medications.
* Prescribed depot medication
* Complex or unstable medical condition interfering with management of psychiatric disorder or requiring ongoing medical treatment from Butajira hospital
* Alcohol or khat dependence or abuse within the last 12 months
* Pregnant or breast-feeding
* Restrained at home
* Refusing to participate in the study

Inclusion criteria for Phase 2 As for Phase 1, but if we are unable to recruit enough participants from the existing Butajira SMD cohort then we will expand recruitment to people with SMD attending the psychiatric out-patient clinic at Butajira hospital. A semi-structured diagnostic interview will be carried out to determine diagnostic eligibility (DSM-IV diagnosis of schizophrenia or schizoaffective disorder, bipolar disorder or major depressive disorder). For participants recruited from Butajira hospital psychiatric out-patient clinic, the minimum age will be 25 years and the participants should have had their first contact with specialist mental health services at least two years prior to recruitment into the trial to ensure comparability with the Butajira SMD cohort sample.

Exclusion criteria for Phase 2

* Current active suicide intent
* Prescribed Thioridazine, Valproate, Lithium or second generation antipsychotic medications (Risperidone and Olanzapine).
* Pregnant or breast-feeding and prescribed depot
* Refusing to participate in the study
* Medical condition requiring ongoing medical treatment from Butajira hospital
D: Inclusion Criteria:

* Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11)
* BMI between ≥ 27 and \< 40

Exclusion Criteria:

* Diagnosis of psychosis, bipolar disorder or substance abuse dependence and/or a high level of suicide risk.
* Use of weight loss medication or medications that interfere with appetite.
* Cushing or Prader-Willi syndromes
* History of bariatric surgery
* Patients who are already in treatment

Answer: B