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HIV/AIDS clinical trials

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NCT ID: NCT04206241 Completed - HIV Infections Clinical Trials

Assessing the Feasibility, Acceptability and Effects Of HIV Birth Testing In Maternity Settings In Zimbabwe

Start date: January 1, 2018
Phase:
Study type: Observational

This study aims to assess the feasibility and, acceptability and effects of implementing HIV testing at birth testing using point-of-care (POC) HIV nucleic acid testing (NAT) in maternity settings.

NCT ID: NCT04195776 Completed - HIV/AIDS Clinical Trials

Evaluating Distribution of a Tenofovir Douche With Tap Water Douching and Simulated Receptive Anal Intercourse

DREAM-02
Start date: June 1, 2021
Phase: Phase 1
Study type: Interventional

DREAM-02 is a phase 1, open label study to evaluate different sequences of tap water douching and simulated receptive anal intercourse (sRAI) in the presence of a tenofovir douche designed to confer protection from Human Immunodeficiency Virus (HIV) acquisition. DREAM-02 will assess the safety and pharmacokinetics (PK) of different sequences of administration of tap water (H2O) and rectal tenofovir (TFV) douches to more accurately represent the community practice of commonly using cleansing douches prior to RAI, and occasionally after RAI. DREAM-02 results are essential to gain understanding of Tenofovir diphosphate (TFV-DP) concentrations at various anatomic distances in the colon, and how those concentrations may be modified by sRAI, seminal fluid, and sequence of cleansing tap water douches.

NCT ID: NCT04192487 Completed - Healthy Volunteers Clinical Trials

Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV+ Patients With Non-Infectious Diarrhea

Start date: October 22, 2019
Phase: Phase 4
Study type: Interventional

This study is intended to evaluate: 1. Any changes in the gut microbiome from baseline compared to end of study in both healthy (HIV-negative) subjects and HIV+ patients with or without chronic diarrhea, following one month of treatment with crofelemer (Mytesi), delayed release 125 mg tablets twice daily (BID) following one month of treatment. 2. The safety and tolerability of crofelemer, (Mytesi) delayed release 125 mg tablets BID in healthy (HIV-negative) volunteers and HIV+ patients following one month of treatment.

NCT ID: NCT04180280 Completed - HIV/AIDS Clinical Trials

Comparative Effectiveness of Brief HIV Care Counseling

SWIMS2
Start date: June 23, 2017
Phase: N/A
Study type: Interventional

Retention in care and persistent adherence to antiretroviral therapy is necessary for the successful treatment of HIV infection. Alcohol use is known to impede the health care and health outcomes of people living with HIV. The proposed comparative effectiveness study will evaluate the outcomes as well as the facilitators and barriers to implementing a theory-based alcohol counseling intervention that objectively monitors HIV treatment adherence with corrective feedback and increases care engagement delivered by cell phone in resource limited clinical settings.

NCT ID: NCT04163341 Completed - Depression Clinical Trials

Tailored Response to Psychiatric Comorbidity to Improve HIV Care Engagement in the United States

TRACE
Start date: October 23, 2020
Phase: N/A
Study type: Interventional

This pilot randomized clinical trial will randomize 60 participants 1:1 to either enhanced usual care or to adapted CETA, a counseling intervention for HIV care engagement plus depression, anxiety, PTSD, and/or substance use.

NCT ID: NCT04151498 Completed - HIV/AIDS Clinical Trials

HIV Reengagement and Assessment Mobile Program (Project RAMP)

Start date: May 29, 2020
Phase: N/A
Study type: Interventional

The North Carolina Bridge Counselor system is designed to help link out of care HIV positive patients back into HIV care. It has improved initial linkages and patient re-engagement overall, but for a sizable group of patients, the current system has not been effective, leaving a population of hard-to-reach, lost-to-care patients who remain out of care. There is limited understanding of the lived experiences of patients who fall out of HIV care and become recalcitrant to re-engagement because they are difficult to reach and therefore underrepresented in research. Out of care HIV+ patients who have not reengaged in care following the standard of care who chose to enroll in the study will participate in 2 semi-structured interviews and receive a field-based HIV re-engagement and treatment intervention (Project RAMP). Project RAMP will consist of up to 4 visits from an outreach research nurse designed to serve as an "on-ramp" to HIV care. At these visits, the outreach number will counsel on HIV care and treatment and obtain a medical history and labs. Results will be communicated to the participant's clinic provider in an effort to both encourage the patient to return to care and facilitate more rapid antiretroviral therapy (ART) initiation by the clinic provider. The research team will also provide the participant in-person assistance with scheduling a clinic visit. Clinic providers may re-initiate ART prior to the reengagement clinic visit, with adherence support provided by the outreach nurse.

NCT ID: NCT04147832 Completed - HIV/AIDS Clinical Trials

Epividian / AHF: Positive Pathways - HIV Retention in Care

Start date: October 5, 2020
Phase:
Study type: Observational

The primary objective of this study is to evaluate the effectiveness of a clinical decision support system (CDSS) combined with enhanced patient contact to retain HIV+ patients in care with AIDS Healthcare Foundation. Specifically, the study aims to evaluate the effectiveness of having the patient's primary caregiver (or dedicated case manager) telephone the patient when the patient is identified as a significant risk to loss of follow-up (at-risk patients) based upon pre-defined criteria. The secondary objective Gain a better understanding about the implementation of the study's procedures in clinical practice by evaluating survey responses delivered to participating healthcare providers and AHF staff members engaging with the study's intervention.

NCT ID: NCT04121962 Completed - HIV/AIDS Clinical Trials

A Pilot Peer Mentor Intervention That Trains Black Men Who Have Sex With Men (BMSM) to Use and Promote Uptake of HIV/STI Self-Testing to Peers and Sex Partners: STAR Study (Self-Testing at Your Residence)

STAR
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

The objectives of the study are to assess the feasibility, reach and preliminary efficacy of a brief intervention that trains Black men who have sex with men [referred to as Index] (a) to use home-based testing for HIV and sexually transmitted infections and (b) promote home-based testing to their peers and sexual partners.

NCT ID: NCT04117984 Completed - HIV/AIDS Clinical Trials

Swaziland HIV Incidence Measurement Survey 2

SHIMS2
Start date: August 30, 2016
Phase:
Study type: Observational

The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators. This is a two-stage cluster sampled cross-sectional survey of 6,417 randomly selected households in Swaziland. Approximately 20,292 eligible persons will be approached (4,664 participants 0-14 years; 12,563 participants 15-49 years; 3,065 participants 50 years and older). Of the sample approached, 15,403 are expected to agree to a blood draw for home-based HIV rapid testing including 3,361 participants 0-14 years; 9,680 participants 15-49 years; and 2,362 participants 50 years and older. SHIMS 2, 2016 will characterize HIV incidence, prevalence, viral load suppression, cluster of differentiation 4 (CD4) T-cell distribution, and risk behaviors in a household-based, nationally-representative sample of the Swazi population and will describe uptake of key HIV prevention, care, and treatment services.

NCT ID: NCT04115813 Completed - HIV/AIDS Clinical Trials

Project YES! Youth Engaging for Success

Project YES!
Start date: December 15, 2017
Phase: N/A
Study type: Interventional

Youth-led strategies remain untested in clinic-based programs to achieve viral suppression (VS) and reduce self-stigma (feelings of worthlessness/shame) among adolescents and young adults (AYA) living with HIV in sub-Saharan Africa. In response, Project YES! will conduct a randomized controlled trial to test the impact of a theory-based intervention that places trained and paid HIV-positive youth peer mentors (YPMs) in four HIV clinics in Ndola, Zambia. AYA, ages 15 to 24 years, will be randomly assigned to either an intervention arm, consisting of monthly one-on-one and small group sessions with a YPM and optional caregiver support groups, or a usual care arm. Survey data and blood samples will be collected and analyzed to test the hypothesis that youth who are in the intervention group will experience more viral suppression than youth in the comparison group.