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HIV clinical trials

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NCT ID: NCT06046079 Not yet recruiting - HIV Clinical Trials

Predictors of Health Service Utilizations Among Key Population in Washington DC

Start date: September 15, 2023
Phase:
Study type: Observational

The primary objective of the proposed study is to investigate how PrEP use might result in an increase in the utilization of health and social services offered at a local community-based organization.Our primary hypothesis is that we will observe higher utilization of sexual health (STI screenings), psychosocial health (psychotherapy, and substance use treatment) and other social services (emergency cash assistance, food pantry, transportation assistance, clothing,and housing resources) among PrEP users (LAI-PrEP or daily oral) compared to participants who are PrEP naïve over the 12-month follow-up period.

NCT ID: NCT06044792 Not yet recruiting - Hiv Clinical Trials

The Influence of Primary HIV-1 Drug Resistance Mutations on Immune Reconstruction in PLWH

Start date: September 30, 2023
Phase:
Study type: Observational

Since the reasons for differential immune reconstitution in HIV-infected patients are still not fully understood, we considered it reasonable to investigate whether the presence of primary HIV drug resistance mutations could be one of the factors of inadequate immune reconstitution. Evaluation of unfavorable factors of immune reconstitution can help identify patients at risk of persistently low CD4 cell counts and CD4:CD8 ratios and requiring careful monitoring for progression to AIDS.

NCT ID: NCT06034938 Not yet recruiting - Hiv Clinical Trials

DOR/TDF/3TC Switch With M184V/I in People With Controlled HIV (Drive Off-Road)

DOR
Start date: December 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this pilot, phase 2, single-arm, clinical trial is to assess the antiretroviral combination Doravirine (DOR)/Lamivudine (3TC)/Tenofovir Disproxyl Fumarate (TDF) in participants with suppressed HIV who previously developed M184V/I mutation that confers resistance to 3TC. The main question it aims to answer is to explore the rate of HIV suppression 24 weeks after the switch to DOR/3TC/TDF. The study follow-up will continue until 48 weeks. Other endpoints will be metabolic changes, weight changes, modification in the HIV-DNA mutations overtime. Eligible participants will switch from their prior regimen to DOR/3TC/TDF with careful HIV-RNA monitoring.

NCT ID: NCT06022809 Not yet recruiting - HIV Clinical Trials

Comparative Effectiveness of Individual Versus Group-Level Interventions to Reduce Human Immunodeficiency Virus (HIV)/ Sexually Transmitted Infections (STI) Incidence

Start date: October 25, 2023
Phase: N/A
Study type: Interventional

The HIV diagnosis rate among African-born Black women is the highest of all Black individuals living in the US. Correct and consistent use of condoms and use of pre-exposure prophylaxis (PrEP) are two effective means of decreasing HIV risk among women, but they remain suboptimal among Black women. The specific aims of this study are: 1. To culturally adapt two widely utilized, evidence-based HIV prevention interventions originally designed for US born Black women (Sister-to-Sister (S2S) and Sisters Informing Sisters about Topics on AIDS (SISTA)) for use by African-born women 2. To conduct a randomized controlled comparative effectiveness trial (RCT) to determine the effectiveness of adapted versions of S2S versus SISTA on increasing condom use and PrEP uptake among African-born women. The adapted versions of these interventions will be given new names that resonate with the African culture. The adapted version of S2S intervention will be called "Dada Kwa Dada (DKD)" intervention while the adapted version of SISTA intervention will be called "DADA" intervention. "DADA" means "Sister" in Swahili and other languages in Eastern and Western Africa.

NCT ID: NCT06016114 Not yet recruiting - Hiv Clinical Trials

Analysis of the Reservoir in Individuals Controlling HIV Infection

ARCH
Start date: December 1, 2024
Phase:
Study type: Observational

The aim of this study is the gain new insights into HIV latency in HIV controllers through extensive blood an tissue sampling (lymph node, colon biopsies, placenta) from 25 individuals living with HIV and healthy individuals.

NCT ID: NCT06015581 Not yet recruiting - Hiv Clinical Trials

Scaling Up Implementation Strategies to Improve the DIAGNOSE and PREVENT Pillars for Young MSM in Florida

YACHT
Start date: June 2024
Phase: N/A
Study type: Interventional

In this study, investigators will test the YACHT package in 42 FDOH contracted Counseling, Testing and Referral (CTR) agencies across Florida's seven End the HIV Epidemic (EHE) counties. The study is powered on both effectiveness outcomes (number of HIV tests of Young Sexual Minority Men - YSMM) and implementation outcomes, consistent with a type 2 hybrid trial. It is hypothesized that YACHT will improve providers' fidelity to Tailored Motivational Interviewing (TMI) when delivering risk reduction counseling (RRC) and PrEP referrals (implementation outcomes) and will increase testing among YSMM (effectiveness outcome). Investigators will use an innovative stepped wedge design to test the YACHT package, including a second randomization to explore ongoing quality management (QM) with mystery shoppers (MS) as a sustainment strategy. The study also contains a qualitative component based on the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to further understand the context of implementation and sustainment (sequential explanatory mixed methods).

NCT ID: NCT06006143 Not yet recruiting - Hiv Clinical Trials

Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 2

HARP
Start date: January 1, 2025
Phase: N/A
Study type: Interventional

This study seeks to determine the feasibility, acceptability, and preliminary efficacy of an intervention consisting of off-label use of a medication with strong efficacy data for alcohol use disorder (AUD) with medical management and a clinical pharmacist-delivered behavioral intervention in reducing alcohol use among individuals with HIV and AUD.

NCT ID: NCT05994742 Not yet recruiting - HIV Clinical Trials

An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM

Co-SAM
Start date: July 1, 2024
Phase: Phase 3
Study type: Interventional

Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of malnutrition. Community-based management of acute malnutrition using ready-to-use therapeutic food (RUTF) has transformed outcomes for children with uncomplicated SAM, but those presenting with poor appetite or medical complications (categorised as having 'complicated' SAM) require hospitalisation. Data show that pneumonia, diarrhoea and malaria are leading causes of death in children with complicated SAM after discharge from hospital. High risk of infectious deaths suggests that sustained antimicrobial interventions may reduce mortality following discharge from hospital. Furthermore, children with complicated SAM respond less well to nutritional rehabilitation, and oftentimes are discharged to a home environment characterised by poverty and multiple caregiver vulnerabilities including depression, low decision making autonomy, lack of social support, gender-restricted family relations, and competing demands on scarce resources. Caregivers have to navigate diverse challenges that impede engagement with clinical care after discharge from hospital. The objective is to address the biological and social determinants of multimorbidity in children with complicated SAM by developing multimodal packages of interventions and testing them in a 5-arm adaptive randomized controlled clinical trial, with death/hospitalization or failed nutritional recovery as the primary outcome.

NCT ID: NCT05979311 Not yet recruiting - HIV Infections Clinical Trials

A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy

VOGUE
Start date: December 29, 2023
Phase: Phase 3
Study type: Interventional

This study will compare safety, efficacy, participant reported outcomes and implementation outcomes of a fixed dose combination (FDC) of a two-drug regimen dolutegravir (DTG) plus lamivudine (3TC) and a three-drug regimen FDC of bictegravir (BIC), emtricitabine (FTC) and tenofovir alafenamide (TAF) in HIV-1 infected adult participants who have not previously received antiretroviral therapy.

NCT ID: NCT05967208 Not yet recruiting - HIV Clinical Trials

Confidential Social Network Referrals for HIV Testing

CONSORT
Start date: May 1, 2025
Phase: N/A
Study type: Interventional

Despite worldwide efforts to promote HIV testing, rates of testing remain low. The purpose of this study is to evaluate the acceptability, efficacy, and cost-effectiveness of confidential SMS-based social network referrals for HIV testing as a means of reaching high-risk individuals and prompting them to test for HIV. To accomplish this purpose, the study has 5 specific aims: Aim 1 will conduct qualitative, formative work to identify desirable provider- and client-side characteristics of a confidential SMS-based HIV testing referral system. Aim 2 will adapt an existing mHealth system (mParis) to add CONSORT functionality. Aim 3 will pilot-test the CONSORT system to collect preliminary data on the system's acceptability, performance, and potential efficacy. Aim 4 will evaluate the acceptability and efficacy of CONSORT in a randomized controlled trial. Aim 5 will evaluate the incremental cost-effectiveness of CONSORT vs. other referral options. If CONSORT is shown to be acceptable, effective, and cost-effective, such mobile-phone supported, chain-referral methods could greatly improve the cost-effectiveness of HIV testing efforts.