Healthy Choices to Promote Health and Reduce Risk in HIV-Infected Youth

Healthy Choices is a randomized clinical trial examining the efficacy of motivational
enhancement in reducing risk and promoting healthy behaviors. This study will use a sample of
225 youth (180 after attrition), ages 16-24, of whom 90 will receive the intervention,
referral, and standard care, and 90 will receive referral plus standard care. The sample will
be drawn from five study sites. Using parallel screening, recruitment will target 100 youth
with an adherence problem, 100 youth with a substance use problem, and 25 youth with a sexual
risk problem. A repeated measures design will be used for the proposed study. Primary outcome
measures are drug and alcohol use, condom use, and HIV medication adherence. Youth will
complete an initial data collection session (baseline) during which questionnaire and
interview measures will be administered. Blood specimens for viral load and CD4+ count will
also be obtained.

Randomization procedures will take place after completion of the baseline assessment.
Participants who are randomized to the intervention group will participate in four sessions
for approximately 3 months and will also receive standard care plus individualized referrals.
The control group will receive standard care and individualized referrals. All five sites
offer comprehensive, multidisciplinary care including social work and case management
services and access to mental health services. Participants will receive a three-month
post-test designed to coincide with ME completion. Subsequent post-tests will occur at 6, 9,
12, and 15 months after baseline data collection (3, 6, 9, and 12 months after ME
completion).

Inclusion Criteria:

- HIV infection as documented by professional referral and medical record review. HIV+
participants who are self-referred and not in medical care will be required to provide
documentation of test results.

- Males or females between the age of 16 years and 0 days and 24 years and 364 days at
the time of study enrollment.

- Reports having ever engaged in at least 2 of the following 3 behaviors based on
screening questionnaire:

- taken prescribed antiretroviral medications, OR been told by his/her physician
that he/she should be on antiretroviral medications (whether he/she takes them or
not);

- vaginal or anal sex, OR

- alcohol or drug use.

- At least one of the 3 aforementioned behaviors are currently at a problem level, based
on screening questionnaire:

- taking currently prescribed antiretroviral medications <90 % of the time in the
last month,

- having unprotected intercourse within the last 3 months,

- demonstrating problem level alcohol and/or drug use as measured during screening.

- Able to understand spoken and written English sufficiently to provide consent/assent
and be interviewed and participate in study intervention.

- Not intending to relocate out of the current geographical area for the duration of
study participation.

Exclusion Criteria:

- History of any psychiatric thought disorder (e.g., schizophrenia, schizoaffective
disorder).

- Currently involved in behavioral research (assessment or intervention) targeting
adherence, sexual risk, or alcohol and/or drug substance abuse OR currently involved
in a substance abuse treatment program.