Effectiveness of Enhanced Counseling and Observed Therapy on Antiretroviral Adherence in People With HIV

HIV is a virus that can lead to acquired immunodeficiency syndrome (AIDS), a disease that
breaks down the immune system and allows for entry of life-threatening secondary infections.
HIV is transmitted through the exchange of bodily fluids, primarily through sexual
intercourse. Antiretroviral therapy (ART) has proven to be an effective treatment for
inhibiting the replication of HIV, allowing for improved quality of life and survival.
However, the long-term effectiveness of ART depends on strict adherence to a prescribed
medication regimen. Previous studies have indicated that observing patients while they take
their medications for a period of time can improve adherence to their prescribed drug
regimens. This study will evaluate the effectiveness of enhanced counseling (EC) alone
versus EC combined with modified directly observed therapy (mDOT) at improving medication
adherence in people with HIV.

Participants in this 48-week study will be randomly placed into one of the following three
treatment groups:

- Group 1 participants will receive standard care, which will involve the care that the
clinic staff normally provide to all patients on HIV therapy.

- Group 2 participants will receive EC.

- Group 3 participants will receive EC with mDOT.

All participants will continue to take the anti-HIV medication regimen prescribed by their
health care provider. However, participants will be asked to keep one medication type in a
bottle that has a special Micro-Electro-Mechanical System (MEMS) cap. This electronic cap
will record each time the participant opens the bottle. Participants will meet with study
staff for MEMS cap data collection once weekly for the first 4 weeks, every 2 weeks up to
Week 12, and then every 4 weeks thereafter.

EC will consist of 30- to 45-minute counseling sessions about medication adherence.
Participants will meet in person with a counselor for the first five sessions, occurring at
baseline and Weeks, 1, 2, 6, and 11. An additional five counseling sessions will be
conducted by phone during Weeks 4, 9, 15, 19, and 23. Participants receiving mDOT will have
their doses of HIV medication delivered to them by an mDOT worker for the first 24 weeks of
treatment. Participants will select a time and location to meet with an mDOT staff member,
who will then provide the daily doses of drugs and observe participants taking those drugs.
Participants will meet with an mDOT worker 5 times a week from baseline to Week 16. Starting
at Week 17, the number of weekly meetings will gradually taper until Week 24 when there will
be no meeting and participants will return to obtaining and taking their HIV medications as
done prior to study enrollment.

Evaluation visits will occur for all participants at baseline and Weeks 12, 24, 36, and 48.
Evaluation sessions will last 45 minutes to 1 hour and will include questionnaires about
adherence, knowledge and attitudes about HIV and HIV therapy, quality of life, support
systems, health status, medical history, drug and alcohol use, and satisfaction with HIV
care. Blood samples will also be taken to measure CD4 cell count and amount of virus in the
blood.

Inclusion Criteria:

- Patient at participating clinical site

- English-speaking

- Initiating new ART (new or change in therapy) or nonadherent to ART as documented by
care provider's assessment, patient self-report, and consistent HIV RNA laboratory
results

- Lives within 45-mile radius of participating clinical site or able to participate in
observed therapy procedures

Exclusion Criteria:

- Pregnancy