Following 20 observable medication doses under an initial DOT study group assignment of in-person DOT (ipDOT), patients will be assigned (crossed-over) to electronic DOT (eDOT) to collect data on another 20 observable medication doses.

Following 20 observable medication doses under an initial DOT study group assignment of electronic DOT (eDOT), patients will be assigned (crossed-over) to in-person DOT (ipDOT) to collect data on another 20 observable medication doses.

Tuberculosis

Drug-resistant Tuberculosis

Adherence, Medication

Adherence, Patient

Electronic DOT is the use of electronic communication methods to observe patients swallow anti-TB drugs and monitor for medication side effects. This study will use two variations of electronic communication methods, referred to as "electronic directly observed therapy" or "eDOT". This includes: (1) eDOT conducted "live" in which TB program staff interact with patients via a computer or phone application as they ingest their medication (eDOT-live), and (2) eDOT conducted using "time stamped, recorded" videos in which TB program staff log into an electronic system and review videos recorded by patients in order to verify that patients ingested their medication doses as scheduled (eDOT-recorded).

Electronic DOT

A trained person is in the physical presence of patients as anti-TB drugs are ingested.

In-person DOT

Morrisania Chest Center

Fort Greene Chest Center

Corona Chest Center

Washington Heights Chest Center

An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment

An Evaluation of Traditional Directly Observed Therapy and Electronic Forms of Directly Observed Therapy for Tuberculosis Treatment

The proportion of medication doses that are directly observed by staff.

The proportion of medication doses not directly observed due to equipment malfunction or loss, staff unavailability, patient travel/ work/ school, inclement weather, or other reasons.

Time, measured in days, in which participants experience initial symptoms of medication side effects to when they receive medical attention for the medication side effects they are experiencing, either through consultation with a physician, urgent care or emergency room visits, or hospital admission across DOT methods.

Number of participants by gender, race, ethnic origin, country of birth, primary language spoken, and employment who adhere to TB treatment. Additionally, the number of patients with a history of contact with persons diagnosed with multi-drug resistant TB, incomplete treatment for latent TB infection, diabetes, renal disease, immunosuppression, hepatitis, a history of homelessness, a history of substance abuse, a history of incarceration, a history of a prior TB diagnosis who adhere to TB treatment.

Compare the proportion of participants completing treatment to those lost to follow-up or refused further treatment, transfer or move, experience treatment failure, or expire (with death attributable to tuberculosis) across DOT methods.

After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT) during the cross-over period, they will be asked to report which DOT method they prefer, and the reasons for their preference.

After participants complete 40 doses of TB medication (20 doses using ipDOT and 20 doses using eDOT), participants will be asked to complete the Patient Opinion Questionnaire to assess their perceptions of the quality of care across DOT methods and satisfaction with patient-staff relationships/rapport.

Any proposal for additional analysis of study data must be agreed to in advance by the NYC DOHMH BTBC and CDC investigators.
These criteria will not apply to public-use data that have been made available in accordance with CDC's policy on data sharing. Persons who use publicly available data will be asked to acknowledge both the NYC DOHMH BTBC and CDC.

Centers for Disease Control and Prevention

New York City Department of Health and Mental Hygiene

Columbia University

Eight weeks of daily treatment with rifampin, isoniazid, pyrazinamide, and ethambutol, followed by Eighteen weeks of daily treatment with rifampin and isoniazid. All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose.
Study drug doses: rifampin, 600 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg.

Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and ethambutol, followed by Nine weeks of daily treatment with rifapentine and isoniazid. All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose.
Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; ethambutol, < 55kg 800 mg, >= 55-75 kg 1200 mg, >75 kg 1600 mg.

Eight weeks of daily treatment with rifapentine, isoniazid, pyrazinamide, and moxifloxacin, followed by Nine weeks of daily treatment with rifapentine, isoniazid, and moxifloxacin. All drugs are administered orally, seven days/week, directly observed by a health care worker at least five of the seven days each week. Pyridoxine (vitamin B6), 25 or 50 mg, is administered with each study dose.
Study drug doses: rifapentine 1200 mg; isoniazid, 300 mg; pyrazinamide, < 55kg 1000 mg, >= 55-75 kg 1500 mg, >75 kg 2000 mg; moxifloxacin, 400 mg.

A rifamycin with activity against Mycobacterium tuberculosis

Rifapentine

Moxifloxacin

Rifampin

Isoniazid

Pyrazinamide

Ethambutol

Pyridoxine

Mulago Hospital

Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis

TBTC Study 31 PK/PD: Population Pharmacokinetic and Pharmacodynamic Study of Efficacy and Safety of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis in the Study 31 Treatment Trial: Intensive PK Sampling

AIDS Clinical Trials Group

No intervention mothers will recieve standard maternal and child care education

Peer counseling intervention group will recieve nutrition education on initiation of breastfeeding within one hour of delivery, continuation of exclusive breastfeeding until six months, and timely introduction of safe, nutritionally adequate complementary feeding after six months.

Infant Malnutrition

Pregnant Women

Lactating Mother

Breastfeeding

Infant Nutrition

Stunting

Peer counseling on infant feeding

Mirpur

Peer Conselling Infant Feeding Education Program

Peer Counselling to Improve Feeding Practices and Reduce Malnutrition in Children 0-2 Years in Bangladesh

We expect children in the intervention group (mothers getting counselling on breastfeeding and complementary feeding) will attain a better linear growth compare to control group (not receiving counselling).

Secondary objectives
The percentage of women exclusively breastfeeding (breast milk and no other foods or milk based liquids) their infants at 3 and 6 months will be increased, in the peer counselling group, compared with mothers without the intervention.
The percentage of children consuming foods from >4 food groups at 9, 12, 15 and 18 months will be increased, in peer counselling group, compared with mothers without the intervention.

International Centre for Diarrhoeal Disease Research, Bangladesh

University of Sydney

Group 1 will receive immunosuppression and AC2993; then immunosuppression only

Group 2 will receive AC2993 only; then neither immunosuppression nor AC2993

Group 3 will receive immunosuppression and AC2993; then immunosuppression and AC2993

Group 4 will receive AC2993 only; then AC2993 only

Diabetes Mellitus

Dose-escalation beginning with 2.5 μg administered subcutaneously twice per day (BID); then to 2.5 μg four times a day (QID); then to 5 μg four times a day; then to 10 μg four times a day.

AC2993 (exenatide)

2 mg/kg intravenously infused over 30 minutes every month for 12 months

daclizumab (immunosuppressive)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

Effect of AC 2993 (Synthetic Exendin-4) - Administered Alone or in Combination With Daclizumab - on Islet Function in Patients With Type I Diabetes

Assess whether patients treated with AC2993 (with or without concomitant immunosuppression) will display at least a 50% improvement in their basal C-peptide level. C-peptide level is a surrogate measure for insulin production.

tuberculosis/carbohydrate

An Evaluation of Traditional Directly Observed Therapy (DOT) and Electronic DOT for TB Treatment

Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis

Peer Conselling Infant Feeding Education Program

Effect of AC2993 With or Without Immunosuppression on Beta Cell Function in Patients With Type I Diabetes

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