A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV

• Register: ClinicalTrials.gov
• Last refreshed on: 19 September 2022
• Main ID: NCT03154320
• Date of registration: 24/03/2017
• Prospective Registration: Yes
• Primary sponsor: Brigham and Women's Hospital
• Public title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
• Scientific title: A Trial of Same-Day Testing and Treatment to Improve Outcomes Among Symptomatic Patients Newly Diagnosed With HIV
• Date of first enrolment: November 6, 2017
• Target sample size: 500
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03154320
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Haiti

Contacts

• Name: Serena P Koenig, MD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women of =18 years of age

- Presence of cough, fever, night sweats or weight loss

- Ability and willingness to give written informed consent

- Documentation of positive HIV status (test conducted at GHESKIO)

- Acceptance of HIV diagnosis, defined as affirmative responses to two questions: "I
believe that HIV and AIDS exist" and "I believe that the results of my HIV test show
that I am infected".

Exclusion Criteria:

- Any use of ART in the past

- Treatment for TB in the year prior to screening visit

- Pregnancy or breastfeeding at the screening visit

- Active drug, alcohol use, or mental condition that would interfere with the ability to
adhere to study requirements, in the opinion of the study physician

- Score of <3 for any of the 7 questions on the ART readiness survey

- Planning to transfer care to another clinic during the study period

- Symptoms consistent with WHO stage 4 neurologic disease (cryptococcal meningitis, TB
meningitis; central nervous system toxoplasmosis; HIV encephalopathy; progressive
multifocal leukoencephalopathy)

- Severe illness, classified as one of the WHO "danger signs" of temperature >39 degrees
Celsius, pulse >120 beats/minutes, respiratory rate >30, or inability to walk unaided.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

HIV/AIDS

Tuberculosis

Intervention(s)

Other: Same-Day Treatment

Other: Standard treatment

Primary Outcome(s)

Retention in care with viral suppression [Time Frame: 48 weeks after HIV testing]

Secondary Outcome(s)

Adverse events [Time Frame: 48-week study period]

Time in clinic [Time Frame: First study day and first study month]

Adherence by 3-day self-report [Time Frame: 48 weeks after HIV testing]

Time to death [Time Frame: 48-week study period]

Incidence of immune reconstitution inflammatory syndrome (IRIS) [Time Frame: 48-week study period]

TB diagnosis after ART initiation [Time Frame: 48-week study period]

TB testing characteristics [Time Frame: These diagnostic tests will be conducted during the first week of study enrollment]

Measure of hope and optimism [Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing]

Mortality [Time Frame: 48 weeks after HIV testing]

Adherence by medication possession ratio [Time Frame: 48 weeks after HIV testing]

Viral suppression [Time Frame: 48 weeks after HIV testing]

Coping with HIV diagnosis [Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing]

Mean treatment cost per participant [Time Frame: 48 weeks after HIV testing]

Last missed dose of medication [Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, 48 Weeks]

Patient satisfaction [Time Frame: 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing]

Connectedness to Treatment Setting [Time Frame: 2 Weeks, 12 Weeks, 24 Weeks, and 48 Weeks after HIV Testing]

Treatment failure [Time Frame: 48 weeks]

Secondary ID(s)

AI131998

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Florida International University

University of California, Davis

Analysis Group, Inc.

Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic

Weill Medical College of Cornell University