## Protocol Section
### Identification Module
**NCT ID:** NCT02396979

**Acronym:** Harapan

**Brief Title:** Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia

**Official Title:** Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia

#### Organization Study ID Info
**ID:** 0908005646
#### Organization
**Class:** OTHER
**Full Name:** Yale University
#### Secondary ID Infos
**ID:** R01DA025943
**Link:** https://reporter.nih.gov/quickSearch/R01DA025943
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-26

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2014-12

**Type:** ACTUAL

#### Start Date
**Date:** 2010-01

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2015-03-24
**Type:** ESTIMATED
**Study First Submit Date:** 2015-02-23
**Study First Submit QC Date:** 2015-03-17
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** University of Malaya

**Class:** NIH

**Name:** National Institute on Drug Abuse (NIDA)

#### Lead Sponsor

**Class:** OTHER

**Name:** Yale University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.

### Conditions Module

**Conditions:**

- Human Immunodeficiency Virus

- Acquired Immunodeficiency Syndrome

- Opiate Addiction

- Drug Dependence

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** FACTORIAL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 300

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Methadone induction and management provided

**Intervention Names:**

- Drug: Methadone

**Label:** Methadone Maintenance

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Administration of the Holistic Health Recovery Program (HHRP-M), which is an eight-session substance abuse relapse prevention and harm reduction program administered by a trained substance abuse counselor.

**Intervention Names:**

- Behavioral: Holistic Health Recovery Program

**Label:** Holistic Health Recovery Program

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Methadone induction and management provided in combination with the Holistic Health Recovery Program (HHRP-M).

**Intervention Names:**

- Drug: Methadone

- Behavioral: Holistic Health Recovery Program

**Label:** Methadone Maintenance and Holistic Health Recovery Prorgram

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Standard of care provided for substance abuse treatment. No methadone maintenance or holistic health recovery program intervention provided.

**Label:** Standard of Care

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Methadone Maintenance

- Methadone Maintenance and Holistic Health Recovery Prorgram

**Name:** Methadone

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Holistic Health Recovery Program

- Methadone Maintenance and Holistic Health Recovery Prorgram

**Name:** Holistic Health Recovery Program

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** The primary outcome is the number of HIV high risk events. This outcome will be constructed from a composite measure counting the number of unprotected vaginal and anal insertive events and needle-or-syringe-sharing events with an HIV- or HIV-status-unknown partner that might result in HIV transmission to an uninfected partner. As such, the primary outcome will be the number of high-risk events during the period of observation in the intervention. All data will be self-reported by the participant.

**Measure:** HIV Risk Events

**Time Frame:** Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12

#### Secondary Outcomes

**Description:** This outcome will be measured by a series of questions that will be used to produce a composite score that will indicate the participant's overall quality of life as it relates to their HIV status. These questions will ask about your general health and your ability to perform daily activities in your life. All data will be self-reported by the participant.

**Measure:** HIV Quality of Life

**Time Frame:** Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12

**Description:** This outcome will be measured as any opioid drug use after release from prison. This outcome will be measured in two ways. First, participants will provide a monthly urine sample that will be tested for the presence of opioids. Second, participants will answer questions about their drug use since the time of their last interview.

**Measure:** Relapse to Drug Use

**Time Frame:** Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12

**Description:** This outcome will be measured by a series of questions about the participant's drug use. These questions will be used to produce a composite score which indicates the severity of the participant's addiction.

**Measure:** Addiction Severity

**Time Frame:** Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12

**Description:** This outcome will be measured by both self-report and objective data from the Malaysian Ministry of Prisons. Self-report questions will be used to ask participants if they have been arrested by police (placed in jail) or incarcerated in prison during the time since the last interview. Objective data will also be obtained from the Ministry of Prisons which will indicate if the participant has been reincarcerated in one of Malaysia's prison during the 12 months since they were initially released from prison.

**Measure:** Reincarceration

**Time Frame:** Any reincarceration to prison during the 12 month post-release follow-up period

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* HIV-infected
* Clinical Diagnosis of Opioid Dependence
* Fluent in Bahasa Malaysia or English
* Within 90 to 180 days of release from prison
* Planning to live in Klang Valley region after release from prison
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy or planning to become pregnant (female only)

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Yale University

**Name:** Frederick L Altice, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** University of Malaya

**Name:** Adeeba Kamarulzaman, M.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Bazazi AR, Culbert GJ, Wegman MP, Heimer R, Kamarulzaman A, Altice FL. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.

**PMID:** 36368939

**Citation:** Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ. Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia. HIV Res Clin Pract. 2019 Feb;20(1):12-23. doi: 10.1080/15284336.2019.1603433. Epub 2019 May 1.

**PMID:** 31303149

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007154

- Term: Immune System Diseases

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000007239

- Term: Infections

- ID: D000015229

- Term: Sexually Transmitted Diseases, Viral

- ID: D000012749

- Term: Sexually Transmitted Diseases

- ID: D000016180

- Term: Lentivirus Infections

- ID: D000012192

- Term: Retroviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000012897

- Term: Slow Virus Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000064419

- Term: Chemically-Induced Disorders

- ID: D000001523

- Term: Mental Disorders

- ID: D000079524

- Term: Narcotic-Related Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC25

- Name: Substance Related Disorders

### Condition Browse Module - Browse Leaves

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M3522

- Name: Acquired Immunodeficiency Syndrome

- Relevance: HIGH

- As Found: Acquired Immunodeficiency Syndrome

- ID: M18250

- Name: HIV Infections

- Relevance: HIGH

- As Found: Acquired Immunodeficiency Syndrome

- ID: M19100

- Name: Behavior, Addictive

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10199

- Name: Immunologic Deficiency Syndromes

- Relevance: HIGH

- As Found: Immunodeficiency

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21837

- Name: Substance-Related Disorders

- Relevance: HIGH

- As Found: Drug Dependence

- ID: M12244

- Name: Opioid-Related Disorders

- Relevance: HIGH

- As Found: Opiate Addiction

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15558

- Name: Sexually Transmitted Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17933

- Name: Sexually Transmitted Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M18640

- Name: Lentivirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15026

- Name: Retroviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15700

- Name: Slow Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M30302

- Name: Chemically-Induced Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M2057

- Name: Narcotic-Related Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000163

- Term: Acquired Immunodeficiency Syndrome

- ID: D000015658

- Term: HIV Infections

- ID: D000007153

- Term: Immunologic Deficiency Syndromes

- ID: D000019966

- Term: Substance-Related Disorders

- ID: D000009293

- Term: Opioid-Related Disorders

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

- ID: D000000996

- Term: Antitussive Agents

- ID: D000019141

- Term: Respiratory System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: AnTuAg

- Name: Antitussive Agents

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: Resp

- Name: Respiratory System Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: AnObAg

- Name: Anti-Obesity Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

### Intervention Browse Module - Browse Leaves

- ID: M11671

- Name: Methadone

- Relevance: HIGH

- As Found: Of Children

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

- ID: M13570

- Name: Phenylpropanolamine

- Relevance: LOW

- As Found: Unknown

- ID: M9238

- Name: Guaifenesin

- Relevance: LOW

- As Found: Unknown

- ID: M186319

- Name: Chlorpheniramine, phenylpropanolamine drug combination

- Relevance: LOW

- As Found: Unknown

- ID: M4312

- Name: Antitussive Agents

- Relevance: LOW

- As Found: Unknown

- ID: M21137

- Name: Respiratory System Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008691

- Term: Methadone

### Misc Info Module

- Version Holder: 2024-05-24
