Please select the eligibility criteria that correspond to the clinical trial below.
Title: Impact of Peer Health Workers and Mobile Phones on HIV Care
Brief Summary: The provision of antiretroviral therapy (ART) in rural, resource-limited settings entails substantial challenges due to limitations in the health service infrastructure and in human resources for HIV/AIDS care. In addition, long geographical distances between providers, care facilities, and patients can represent a significant barrier to appropriate and timely care. The use of peer health workers as frontline adherence supporters and clinical monitors in order to improve care in underserviced settings has been implemented by a number of programs, but the effect of peer support on HIV care outcomes has not been extensively evaluated. Mobile phones have also been proposed as a potential method of improving access to health care in resource-limited environments by expediting communication and data transfer, but rigorous studies on their effectiveness in Africa have not yet been conducted.

The Rakai Health Science Project (RHSP) was founded in 1987 to study the HIV epidemic in the rural setting of Rakai District in southwest Uganda. Since June 2004, the US President's Plan for AIDS Relief (PEPFAR) has enabled the RHSP to provide ART through a community-based distribution system which includes clinical monitoring via a decentralized, mobile clinic approach. By late 2006, the program has screened 4,397 HIV-infected individuals and initiated ART in 849 patients. One of the challenges of providing ART in this setting has been the distance between many patients' homes and the clinic and medical staff trained in HIV care. This distance and the lack of communication channels make frequent clinic contacts difficult and has raised concerns about adherence and management of drug toxicity. This study will investigate whether peer health workers can help support this AIDS care program and improve patient outcomes.

This study is a three armed, community-randomized operations research trial to assess the effectiveness of peer health workers, with and without mobile phones, in improving the delivery of HIV care in the resource-limited Rakai setting. The three arms will be: a) communities with peer health workers, b) communities with peer health workers and mobile phones, and c) control communities without peer health workers.

Study hypotheses include:

* Peer health workers, by supporting adherence and by managing simple clinical issues, will reduce virologic treatment failure and improve ARV adherence compared to patients in communities without peer educators.
* Mobile phone technology used by peer health workers, by more rapidly addressing adherence and clinical problems, will reduce treatment failure and improve adherence compared to patients in communities with peer health workers without mobile phones.


Options:
A: Inclusion Criteria:

* Inclusion in the study is determined by receipt of ARVs in the PEPFAR program.

Exclusion Criteria:

* None
B: Inclusion Criteria:

* HIV-1 positive patients who have maintained an HIV-1 viral load \<200 copies/mL, for at least 3 months.
* Patients must be on their first HAART or have documented viral suppression on a PI-based regimen at the time of any prior change in therapy.
* HAART must consist of either:

  1. A PI (with or without ritonavir) + at least 2 NRTIs or
  2. An NNRTI + at least 2 NRTIs.
* Negative serum pregnancy test.

Exclusion Criteria:

* Patients who have taken any NNRTI prior to their current therapy.
* Patients who have taken a NRTI-only therapy for greater than 7 days prior to their current therapy.
* Patients who are currently taking EFV+FTC+TDF.
* Patients who have a creatinine clearance of \<60 mL/min by Cockcroft-Gault estimation.
* Patients who have experienced virologic failure with any previous ARV therapy.
* Patients who have documented resistance to any of the study agents at any time in the past.
C: Inclusion Criteria:

* Ability to read English
* Stable symptoms of mild to severe heart failure
* Stable medical regimen for heart failure
* On a stable dose of Coreg for at least 2 months
* LVEF ≤40% within the previous 24 months

Exclusion Criteria:

* Uncorrected obstructive or regurgitant valve disease
* Complex congenital heart disease
* Recent ICD or pacemaker placement
* Recent coronary artery bypass surgery or stroke
* Candidate for heart transplanct within 5 months of study start
* Present or planned use of MAO inhibitors, alfpha-blockers, combined alpha-beta blockers, any Class I/II anti-arrythmnic agents, (amiodarone may be used if ≤ 200mg/day). Use of intravenous vasodilator/inotropic agents.
D: Inclusion Criteria:

1. current 9-item Patient Health Questionnaire (PHQ-9) score of 10 or more and
2. current treatment in the HIV clinic.

Exclusion Criteria:

1. patients who do not have access to a telephone,
2. patients with current suicidal ideation,
3. patients with significant cognitive impairment as indicated by a score \< 10 on the HIV Dementia Scale, and
4. patients with a chart diagnosis of schizophrenia.

Answer: A