This study will evaluate the effectiveness of cognitive behavioral coping training in
improving side effect management and treatment adherence in HIV-infected patients who are
taking antiretroviral medications.
HIV is a virus that is transmitted through the exchange of bodily fluids, primarily through
sexual intercourse. HIV infections can lead to acquired immunodeficiency syndrome (AIDS), a
disease that breaks down the immune system and allows for entry of life-threatening
secondary infections. Antiretroviral therapy (ART) has proven to effectively inhibit the
replication of HIV and has resulted in a reduction in HIV-related deaths. People infected
with HIV who are receiving ART, however, may be confronted with negative physical and
emotional side effects. These side effects can impact quality of life (QOL), adherence to
medical care, and decisions about health care. Stress and Coping Theory (SCT) is a
person-centered approach that considers stressful experiences as person-environment
transactions. A cognitive behavioral treatment based upon SCT may help to eliminate or
reduce the negative impact of side effects, improve QOL, and maximize benefit from treatment
among people living with HIV. This study will evaluate the effectiveness of cognitive
behavioral coping training in improving side effect management and treatment adherence in
HIV-infected people who are taking ART medications.
This study will involve two phases. Phase 1 will be conducted over 12 months and will
include two 1-hour interviews with questions about personal life, family, friends,
medications, and medication side effects. After the first interview, participants may be
invited to participate in Phase 2, which will last 18 months.
During Phase 2, participants will complete five 2- to 3-hour interviews occurring at
baseline and Months 3, 6, 12, and 18. Interviews will include questions about personal life,
friends, family, health-related activities, drug-using behaviors, emotions, mental state,
and educational background. Participants will be assigned randomly to one of two treatment
- Group 1 participants will receive five individual sessions of cognitive behavioral
coping training, beginning after the Month 3 interview. The 90-minute sessions will
focus on coping with stress, dealing with medication side effects, and staying on track
- Group 2 participants will receive standard care and one group session of coping
training, which will be held after the Month 18 interview. The group session will cover
the same material that is covered in the individual sessions.
After the last follow-up interview, some participants may also be asked to complete an exit
interview about thoughts and feelings on study participation.
- Confirmed presence of HIV infection
- Currently receiving ART
- Experiencing ART side effects
- Currently enrolled in another trial
- Evidence of psychosis or cognitive impairment