Please select the eligibility criteria that correspond to the clinical trial below.
Title: Venue-Based Recruitment and HIV Prevention for Alcohol and Other Drug (AOD) Using Couples in South Africa
Brief Summary: Couples who use alcohol and other drugs (AOD) in South Africa are at high risk for engaging in risky sex behavior within their relationships and with other sexual partners. In addition, high levels of gender-based violence (GBV) in the Cape Town area intersect with AOD abuse and sex behavior. All of these interconnections raise concern for the importance of HIV prevention strategies within or surrounding drinking venues, where many of these behaviors occur.

The specific aims of this study are as follows:

Aim 1. To characterize the types of drinking venues (e.g., licensure status, size, plumbing, type of alcohol provided), their immediate context (e.g., observed availability and use of other drugs, observable violence and sexual activity), and surrounding neighborhood characteristics (e.g., quality of streets, building structures, and availability of electricity and plumbing) in the sampled neighborhood blocks in several large Black/African and Coloured communities in Cape Town, South Africa.

Aim 2. To refine through qualitative methods the proposed interventions in relation to skills-building to address gender-role expectations, sexual partnering, gender and power, violence, and environments where drinking and sexual risk behaviors occur.

Aim 3. To conduct a randomized group trial to compare the relative efficacy of a comprehensive intervention (Condition 3: Enhanced Couples) to the gender-focused intervention (Condition 2: Gender) and to (Condition 1: Men's Control and Women's CoOp) on reducing alcohol and other drug (AOD) use, sexual risk behavior, and gender-based violence at 6 month follow-ups. Aim 4. To assess the mechanisms through which the intervention effects may occur (e.g., mediators involving self-efficacy and condom mastery, negotiation, and communication skills) and to identify groups for whom the interventions have the greatest effect (e.g., partner characteristics such as race, gender, and age and neighborhood factors such as poverty) on study outcomes of AOD use, sexual risk, and gender-based violence.


Options:
A: Inclusion Criteria:

* female;
* receiving HIV medical care at the AIDS Center;
* chart-documented HIV and chronic HCV infection;
* currently prescribed an antiretroviral (ARV) regimen;
* medically, cognitively, and psychologically capable of study participation;
* laboratory-confirmed recent alcohol use as detected by a Ethylglucuronide (EtG) analysis or self-reported alcohol use

Exclusion Criteria:

* not identifying as biological female
* not HIV and HCV positive
* no laboratory-confirmed or self-reported
* not willing to participate in the trial
* not able to participate in the trial due to medical, cognitive, or psychological issues
B: Men

Inclusion:

* Male
* 18-35
* Identify as Black or Coloured
* Live in one of the target communities- Khayelitsha, Mitchell's Plain and Delft
* Have the same main heterosexual sex partner for at least one year, plan to stay with this partner for at least one year and do not plan to get this partner pregnant within the next year
* Report unprotected sex at least once in the past 90 days with main partner
* Have used alcohol in a tavern or shebeen in the past 90 days
* Spend time in a tavern or shebeen at least weekly

Exclusion

* Have been a part of previous Couples' Health CoOp group study activities
* Are currently enrolled in an HIV research study

Women

Inclusion:

* Female
* 18 or older
* Have the same main heterosexual sex partner for at least one year and plan to stay together with this partner for at least one year and do not plan to get pregnant within the next year with this partner
* Report unprotected sex at least once in the past 90 days with main partner

Exclusion:

* Have been a part of previous Couples' Health CoOp group study activities
* Are currently enrolled in an HIV research study
* Have been a part of the Cape Town Pilot Study or the Western Cape Women's Health CoOp
C: Inclusion Criteria:

* Female sex worker, defined as a woman who self reports exchange of any type of sex including oral, anal, and vaginal sex for money or gifts within the six months prior to study enrollment;
* Self-identifies as a woman;
* 18 years or older;
* Scores between 7-19 on the AUDIT questionnaire;
* Willing to participate in the study and all data collection procedures;
* Lives in Mombasa or plans on residing in Mombasa for 12 months following study enrollment;
* Currently participating in the APHIA II sex worker peer education program; and
* Documentation of negative tests for gonorrhea, Chlamydia, and trichomoniasis.

Exclusion Criteria:

* Scores less than 7 (low-risk drinking) or more than 19 (high-risk drinking/alcohol dependence) on the AUDIT questionnaire;
* Plans to be away in the next 12 months for more than six months or relocate away from the study site;
* Currently participating in another HIV intervention study; or
* Has any other condition that, in the opinion of the investigator or designee, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise with achieving the study objectives.
D: Inclusion Criteria:

* Initial inclusion criteria for overall enrollment (into either the Cohort or RCT study) will be:

  * HIV positive
  * Receiving HIV treatment services at one of the two study clinics
  * Current hazardous alcohol use, defined as an AUDIT score of ≥8 for men and ≥ 4 for women
  * Provides informed consent

Secondary inclusion for enrollment into the RCT will be:

* AUDIT scores that indicate a moderate-to-severe AUD (≥12 for women; ≥16 among men)
* AND/OR: meeting validated symptom criteria for depression (≥16 on Center for Epidemiological Studies-Depression (CES-D), trauma/anxiety (≥2.5 on HTQ), and/or substance use (≥27 for any non-tobacco/alcohol substance on ASSIST)

Exclusion Criteria:

* HIV negative
* Not receiving care at one of the study clinics
* Currently psychotic or actively suicidal
* Unable to provide informed consent

Answer: B