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PrEP clinical trials

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NCT ID: NCT05896423 Active, not recruiting - HIV Clinical Trials

Increasing PrEP Awareness and Demand Among Black Cisgender Women

IPAD-BCW
Start date: August 15, 2023
Phase:
Study type: Observational

This study will develop HIV pre-exposure prophylaxis (PrEP) awareness materials for and with Black cis women and gather feedback on the usefulness of these materials at health care sites. The investigators will also use electronic medical records (EMR) to compare the number of Black cis women who initiate PrEP before and after the awareness materials are piloted, at the two partner research sites, Howard Brown Health and Planned Parenthood of IL. Additional federally qualified health centers and family planning clinics will review the materials and complete a survey on acceptability.

NCT ID: NCT05644834 Recruiting - HIV Prevention Clinical Trials

Pilot Mobile Medical Unit Study for I'm Fully Empowered4Her

IFE4Her
Start date: April 18, 2023
Phase: N/A
Study type: Interventional

The overarching objective for the pilot study is to test the feasibility of using a mobile medical unit as a delivery mode combined with enhanced Pre-exposure Prophylaxis (PrEP) messaging to increase awareness of PrEP and access to PrEP medical services among women living in public housing.

NCT ID: NCT05599581 Recruiting - HIV Clinical Trials

Tu'Washindi RCT: Adolescent Girls in Kenya Taking Control of Their Health

Start date: September 29, 2022
Phase: N/A
Study type: Interventional

This study will test the effectiveness of a youth-designed multilevel intervention, Tu'Washindi, to increase PrEP use and reduce intimate partner violence (IPV) among Kenyan AGYW and to identify implementation challenges and strategies to facilitate future scale-up in programmatic settings to maximize public health impact. Through a cluster randomized controlled trial (cRCT) design, twenty-two administrative wards in Siaya County, western Kenya will be randomized in a 1:1 ratio to receive either the 6-month Tu'Washindi intervention plus usual HIV prevention services or usual HIV prevention services alone. Approximately 72 AGYW will be enrolled from each ward (N= 1,584), with follow-up visits at months 3, 6, and 12 post-enrollment. A mixed methods process evaluation will also be conducted using programmatic data, follow-up questionnaires from trial participants, approximately 500-1000 exit surveys with men, and approximately 100 qualitative interviews with AGYW participants, male partners, and intervention providers. These data will characterize fidelity and quality of intervention implementation, explore and test mechanisms of change, and capture contextual factors influencing intervention outcomes, with the goal of informing future refinement and implementation. The population for this study is AGYW ages 15-24 in Siaya County, Kenya; their male partners, ages 15 or older; and health providers delivering the intervention, ages 18 and above, who are working with this population.

NCT ID: NCT05412433 Recruiting - HIV Prevention Clinical Trials

Clinic-based HIV Identification and Prevention Project Using Electronic Resources

CHIPPER
Start date: October 3, 2022
Phase: N/A
Study type: Interventional

Hybrid Type II effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with HIV risk categorization/scoring will increase pre-exposure prophylaxis (PrEP) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

NCT ID: NCT05194085 Enrolling by invitation - HIV Clinical Trials

Impact of Male Provider Phone Calls to Increase Men's Clinic Linkage After HIVST

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

Evaluate the impact of phone calls from a male counselor in increasing linkage to HIV care and PrEP among male partners of pregnant women attending PMTCT.

NCT ID: NCT05092997 Completed - HIV Clinical Trials

Kingasa Pilot Study

Start date: February 17, 2021
Phase: N/A
Study type: Interventional

In the Kingasa study, the investigators will use a factorial design in order to evaluate both an intervention to increase male partner HIV testing and an intervention for pregnant and postpartum women living with HIV to provide real-time HIV VL load and ART adherence counseling. Specifically, the investigators will evaluate a) whether invitations to wellness visits increase the proportion of male partners who test for HIV and b) whether POC HIV VL tests increase viral suppression among pregnant and postpartum women living with HIV. The research team will also assess the impact of providing male counselor phone call follow-up to men in the wellness visit arm to encourage linkage to HIV care and prevention after HIV testing. Women will be randomized 1:1:1:1 to receive a) standard of care interventions with an invitation letter for male partners for fast-track visit for HIV testing and laboratory HIV testing for women at enrollment and every 6 months until 12 months postpartum, b) invitation letter for male partners for fast track visit for HIV testing and POC VL tests for women at enrollment and every 6 months until 12 months postpartum; c) invitation letter to male partners for wellness visits and laboratory-based HIV VL testing for women at enrollment and every 6 months until 12 months postpartum; and d) invitation letter to male partners for wellness visits and POC viral load testing for women at enrollment and every 6 months until 12 months post-partum. Women who are randomized to receive POC VL will receive same-day ART adherence counseling and those randomized to receive lab-based VL will receive VL results at their next visit with ART adherence counseling based on their VL results.

NCT ID: NCT04868383 Completed - HIV Prevention Clinical Trials

Using Smart Phone Technology to Support PrEP Uptake and Adherence

prep'd
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This is a single arm pilot study of a new smartphone app to support adherence to PrEP medication for HIV prevention in public clinics in Virginia.

NCT ID: NCT04867798 Completed - HIV Clinical Trials

Transgender Men and HIV in Uganda: PrEP Uptake and Persistence

Start date: September 16, 2021
Phase:
Study type: Observational

Transgender men (trans men; assigned female sex at birth but identify as male) are generally thought to be at low risk of HIV acquisition, perhaps because of the assumption that they have sex with cis-gender women. Emerging data from resource-rich settings show that trans men often face many of the same high risks as transgender women (trans women; assigned male sex at birth but identify as female). Trans men report similar rates to trans women of engagement in sex work and engage in unprotected receptive vaginal and/or anal sex with cis-gender men. Additionally, they report high sexual risk-taking behaviors including inconsistent condom use which puts them at risk of HIV and other sexually transmitted infections (STIs). Little is known about HIV risk in trans men globally, and no published data are available from sub-Saharan Africa. We will recruit a cohort of 50 trans men through respondent driven sampling. We will use mixed methods to gain a deeper understanding of the sexual health experiences and risk behaviors of trans men in Uganda. Guided by the Social Ecological Model, we will conduct in-depth interviews with up to 20 trans men to understand individual, interpersonal, community and social contextual factors that influence sexual risk behaviors and HIV/STI risk (Aim 1). In Aim 2, we will characterize HIV and STI prevalence and risk among trans men by conducting a behavioral HIV risk assessment including sexual practices, alcohol and drug use, partner violence, gender dysphoria, male hormone use and willingness to take PrEP. In Aim 3, we will evaluate PrEP uptake and persistence among HIV-negative trans men with HIV risk. Participants will be offered PrEP and followed monthly for 12 months. At quarterly visits, participants will receive integrated next steps adherence counseling and drug level feedback using a point-of-care urine tenofovir lateral-flow immunoassay. Free testing and treatment of common curable STIs (Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis) will be provided. Primary outcomes are: 1) PrEP persistence at 6 and 12 months as measured by tenofovir levels in dried blood spots collected quarterly, and 2) STI incidence. Assessment of PrEP use by trans men will help increase the utilization of HIV services, including HIV and STI testing and PrEP, with a goal of decreasing HIV acquisition.

NCT ID: NCT04772326 Active, not recruiting - PREP Clinical Trials

Impact of Containment and the Current Epidemic on the Sexual Risk-taking of People Using PrEP to Prevent HIV Infection.

CoroPrEP
Start date: February 16, 2021
Phase:
Study type: Observational

People using PrEP to prevent HIV infection have sexual risk-taking behaviors that motivated the prescription of PrEP. Both containment and the current epidemic may affect the sexual behavior of people using PrEP and the risk of acquiring STIs. Hypotheses regarding the impact of the current epidemic-motivated confinement and its gradual lifting are as follows: - A decrease in sexual risk-taking during the confinement period, followed by an increase when the confinement is lifted. - An increase in sexual violence and the use of psychoactive substances. - An impact on PrEP monitoring and compliance. - An increase in the incidence of STIs when the confinement is lifted.

NCT ID: NCT04719364 Recruiting - Stigma, Social Clinical Trials

PrEP Awareness, Barriers and Facilitators for PrEP Uptake, and Dosing Mechanisms on Willingness to Take PrEP Among MSM

MSM
Start date: February 1, 2021
Phase:
Study type: Observational

The investigators are conducting a one and one-half year mixed-methods study to evaluate self-reported sexual risk, knowledge and barriers/facilitators of PrEP use, and preferences of oral, injectable, and implantable PrEP treatment modalities-as a function of race and age, and experience with intersectional discrimination. The first qualitative phase of our study would be conducted over the first eight months, followed by a quantitative phase that will collect data via online cross-sectional survey over the remaining ten months.