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HIV/AIDS

Featured Studies

Featured studies include only those currently recruiting participants. Studies with the most recent start date appear first.

  • Triggered Escalating Real-time Adherence (TERA) Intervention
    Study Type: Interventional
    Start Date: February 1, 2018
    Locations: Jacksonville, Florida; Memphis, Tennessee
    Eligibility: Ages 13–24, Accepts Healthy Volunteers

    Youth Living with HIV (YLWH) often face unique challenges achieving high and sustained rates of adherence to their antiretroviral therapy (ART). Poor adherence can lead to unsuppressed virus, more advanced HIV disease and poorer health outcomes, eventually exhausting treatment options. To date however, there are few demonstrated interventions for youth failing first line therapy. This study will evaluate a novel intervention that uses remote coaching through video enabled counseling sessions, a 'smart' pill bottle that notifies an adherence coach when youth fail to open/close the device around dose time, and problem solving outreach by the coach when and as needed. This intensive 'boot camp' strategy is implemented for 12 weeks followed by observation through 48 weeks.

  • Partners-based HIV Treatment for Couples Attending Antenatal Care
    Study Type: Interventional
    Start Date: November 20, 2017
    Location: Pebane, Zambezia, Mozambique
    Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

    The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms of behavior change, and cost-effectiveness of a partners-focused integrated elimination of mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couples-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. This innovative approach to scaling up EMTCT services, if proven feasible and effective, will be adopted in President's Emergency Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping families with HIV infection live long, healthy lives.

  • Innovative Approaches for Minor Consent: Consent 2.0
    Study Type: Interventional
    Start Date: November 7, 2017
    Locations: Aurora, Colorado; Tampa, Florida; Chicago, Illinois; Baltimore, Maryland
    Eligibility: Ages 14–17, Accepts Healthy Volunteers

    The purpose of this study is to examine how the consent process affects the acceptability of participation in biomedical HIV prevention trials, from the perspective of behaviorally high-risk minors and the parents of minor adolescents.

  • Social Media Based Peer-Led Intervention for HIV Prevention
    Study Type: Interventional
    Start Date: June 16, 2017
    Location: The Bronx, New York
    Eligibility: Ages 18–29, Accepts Healthy Volunteers

    The purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of E-PrEP on reaching young men of color who have sex with men (YMCSM) at high-risk of HIV infection to reduce HIV acquisition. E-PrEP is a peer-designed social media-based health intervention to increase PrEP awareness, knowledge, and motivation as a tool for HIV prevention and to increase linkage to primary care.

  • Improving South African Government Workers' Capacities to Deliver HIV Interventions
    Study Type: Interventional
    Start Date: June 1, 2017
    Locations: Stellenbosch, South Africa; Zithulele, South Africa
    Eligibility: Females, Ages 15–49, Accepts Healthy Volunteers

    The purpose of this study is to address the United States Office of AIDS Research highest priorities: improving the workforce, reducing health disparities, and addressing HIV comorbidities. UCLA will randomize the government-funded community health workers (CHW) from 16 clinics in matched rural areas in the Eastern Cape in South Africa to either: 1) the Accountable Condition (AC) in which additional monitoring and accountability systems that Philani routinely uses are implemented or 2) a Control Condition (CC), of initial Philani training, but ongoing supervision and monitoring consistent with local government practices.

  • Secondary Distribution of HIV Self-tests: an Innovative Strategy for Promoting Partner Testing and Reducing HIV Risk
    Study Type: Interventional
    Start Date: May 24, 2017
    Location: Kisumu, Kenya
    Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

    This cluster randomized trial will assess whether the provision of multiple oral-fluid based HIV self-test kits to HIV-negative women at high risk of acquiring HIV in western Kenya is an approach that promotes HIV testing among women's sexual partners, facilitates better sexual decision making, and reduces women's risk of acquiring HIV.

  • Youth mHealth Adherence Intervention for HIV+ YMSM
    Study Type: Interventional
    Start Date: May 22, 2017
    Location: Philadelphia, Pennsylvania
    Eligibility: Males, Ages 14–24, Accepts Healthy Volunteers

    This study will help determine feasibility, acceptability, and preliminary efficacy of an app for HIV medication adherence over a 3-month period. Participation is 3 months consisting of two study visits: An initial study visit and a 3 month follow up visit with both visits lasting about 60-90 minutes. The participant must use the study application (app) at least once daily, and at study visits, must complete surveys.

  • A Mobile Phone Game to Prevent HIV Among Young Africans
    Study Type: Interventional
    Start Date: March 20, 2017
    Location: Kisumu, Kenya
    Eligibility: Ages 11–14, Accepts Healthy Volunteers

    This project will test the feasibility of an electronic game to prevent HIV among African preadolescents, delivered via inexpensive Android smart phones. In order to collect feasibility data for a future randomized controlled trial, this study involves the pilot-testing of the intervention with a sample of young people in Nyanza region, Kenya, where 11.4% of young women ages 15-24 are HIV-infected. This feasibility study will be carried out with the Kenya Medical Research Institute (KEMRI).

  • The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)
    Study Type: Observational
    Start Date: March 13, 2017
    Location: Harare, Zimbabwe
    Eligibility: Ages 18–35, Accepts Healthy Volunteers

    This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

  • Optimizing HIV PrEP Through Shared Decision Making
    Study Type: Interventional
    Start Date: February 24, 2017
    Location: Boston, Massachusetts
    Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

    The purpose of this study is to test a clinical Decision Aid that will help patients and providers determine if pre-exposure prophylaxis (PrEP) is the right decision. The Decision Aid will be tested in both clinical and non-clinical settings with 80 patient-provider dyads. The investigators hypothesize that the use of the Decision Aid will reduce patient decisional conflict. The investigators predict that it will increase patient and provider knowledge of and intent to initiate PrEP.

  • The Partners Scale-Up Project
    Study Type: Interventional
    Start Date: February 6, 2017
    Location: Thika, Kenya
    Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

    An implementation project to scale-up delivery of antiretroviral-based HIV-1 prevention methods to Kenyan HIV-1 serodiscordant couples in HIV-1 care centers. Pre-exposure prophylaxis (PrEP) as a bridge to antiretroviral therapy (ART) HIV-1 prevention strategy will be introduced into 24 public HIV-1 care centers in central and western Kenya according to national guidelines using a stepped wedge design, stratified by region.

  • Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
    Study Type: Interventional
    Start Date: January 1, 2017
    Location: New Delhi, India
    Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

    Depression is a common perinatal complication that can have a profound, adverse effect on maternal and child health outcomes. The proposed study will directly address this important, but understudied area by evaluating the feasibility and preliminary effect of an innovative, integrated intervention approach, BEST-maCARE [Better Education, Support, Treatment for maternal Capacity, Adherence, REtention in care]. The multi-component intervention is guided by a model drawn from self-regulation and bioecological systems theory. Proactive counseling personalized to the patient and socio-cultural context is delivered by trained clinic personnel (e.g., counselors) to build problem solving and coping skills and linkages to mental health, HIV treatment and ancillary services. The theory-guided intervention approach has been found effective in improving the health behavior and outcomes (e.g., virologic) of vulnerable, marginalized HIV+ women and men in rural and urban settings in the US (AI38858-ACTG 731; R01NR05108). Although the investigators formative research suggests that it is well suited for the target population, its usefulness in addressing significant gaps in care among perinatal women.

    l women with co-morbid conditions in a different socio-cultural, limited resource setting has not been studied.

  • Stigma and Online Counseling to Increase HIV/STI Testing
    Study Type: Interventional
    Start Date: December 1, 2016
    Location: Atlanta, Georgia
    Eligibility: Males, Ages 18 and Older, Does Not Accept Healthy Volunteers

    The alarmingly high rates of HIV/STI (sexually transmitted infections) observed among Black men who have sex with men (BMSM) necessitate a new model for engaging BMSM. New approaches include addressing stigma related concerns and structural barriers in order to increase HIV/STI testing uptake. This research includes a 2 x 2 factorial design to test an intervention that is aimed at increasing HIV/STI testing uptake among BMSM; this design includes testing HIV/STI stigma focused counseling, and online HIV/STI test counseling with at-home, self-administered HIV and STI test kits.

  • Family Planning and HIV in Postpartum Women in Mbarara
    Study Type: Interventional
    Start Date: December 1, 2016
    Location: Mbarara, Uganda
    Eligibility: Ages 18–48, Accepts Healthy Volunteers

    Supporting HIV positive women to delay or prevent an unwanted pregnancy may improve women's health through family planning choices, regular health reviews, and support. A cohort study that was done in Mbarara amongst HIV-infected women documented 50% of the enrolled women having no desire for a (another) child during the 4 years since ART initiation, 51% had a serodiscordant partner, with only 45% using effective contraceptive method. Key predictors of contraceptive use were family planning goals within the DYAD. One of the key predictors of effective contraceptive use was male partner involvement and CD4 count. The WHO recommends dual contraception (use of condoms and a hormonal or permanent method) to prevent both HIV transmission and unwanted pregnancies (WHO,2014).This prospective intervention study aims at providing information on whether continuous family planning accessibility and support has a measurable impact on pregnancy intentions and contraceptive usage among postpartum HIV positive mothers delivering at MRRH, SW Uganda.

  • Positive Connections: COPA2
    Study Type: Interventional
    Start Date: July 1, 2016
    Location: Buenos Aires, Argentina
    Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

    This study proposes to assess the impact of a provider-based intervention to enhance re-engagement and improve retention, adherence, persistence and viral load among challenging patients in Argentina

  • Agricultural Intervention for Food Security and HIV Health Outcomes in Kenya
    Study Type: Interventional
    Start Date: June 1, 2016
    Locations: Nyatike, Migori, Kenya; Migori, Kenya
    Eligibility: Ages 18–60, Does Not Accept Healthy Volunteers

    The purpose of this study is to determine whether this multisectoral agricultural and microcredit loan intervention improves food security, prevent antiretroviral treatment failure, and reduce co-morbidities among people living with HIV/AIDS.

  • Innovative Behavioral Economics Incentives Strategies for Health
    Study Type: Interventional
    Start Date: April 1, 2016
    Location: Mbarara, Uganda
    Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

    The success of combination HIV prevention efforts, including HIV treatment as prevention, hinges on universal, routine HIV testing with effective treatment after HIV diagnosis. The proposed study will evaluate the comparative effectiveness and sustainability of innovative incentive strategies, informed directly by behavioral economics and decision psychology, to promote HIV testing among men and HIV treatment among HIV-infected adults in rural Uganda.

  • Addressing Psychosocial Comorbidities in HIV Treatment and Prevention
    Study Type: Interventional
    Start Date: March 1, 2016
    Location: Miami, Florida
    Eligibility: Ages 18–65, Does Not Accept Healthy Volunteers

    Project AProaCH is an open pilot trial of a cognitive behavioral therapy (CBT) for individuals with HIV with various psychological comorbidities, which the investigators call "syndemics". Syndemics are co-occurring psychosocial problems that interact with each other and with health behavior such as HIV sexual transmission risk behavior and adherence to self care.

  • Striving Towards EmPowerment and Medication Adherence (STEP-AD)
    Study Type: Interventional
    Start Date: December 1, 2015
    Location: Boston, Massachusetts
    Eligibility: Females, Ages 18 and Older, Does Not Accept Healthy Volunteers

    Striving Towards Empowerment and Medication Adherence (STEP-AD) is a research study aimed at developing an intervention for Black women living with HIV to address psychosocial factors (i.e. abuse/trauma histories, racial discrimination, HIV stigma/discrimination, and prescribed traditional gender roles) that have been associated with medication nonadherence or poor HIV outcomes (e.g. viral load, CD4), but are unaddressed in existing interventions.

  • Motivational Enhancement System for Adherence (MESA) for Youth Starting ART
    Study Type: Interventional
    Start Date: August 1, 2015
    Locations: Los Angeles, California; Washington, District of Columbia; Detroit, Michigan; Phildelphia, Pennsylvania
    Eligibility: Ages 16–24, Does Not Accept Healthy Volunteers

    This study is a multi-site (Detroit, MI; Los Angeles, CA; Philadelphia, PA, and Washington, DC), two-group randomized controlled trial testing a two-session intervention designed to increase motivation for adherence to antiretroviral treatment (ART) among youth living with HIV (YLH) newly recommended to begin medications. Participants are randomized to receive the intervention, Motivational Enhancement System for Adherence (MESA), or the control condition, System for Health (SH: healthy eating and physical activity information). Both groups receive the standard of care regarding the initiation of ART. ART adherence (visual analog scale and hair sample assay) and health outcomes (viral load results, and CD4 counts) are assessed. Additionally, potential mediators (HIV knowledge, motivation for adherence, and self-efficacy for adherence) and predictors of intervention response (substance abuse, mental health symptoms, executive functioning, and stressful life events) are assessed.

  • Traditional Healers as Adherence Partners for Persons Living With HIV in Rural Mozambique
    Study Type: Interventional
    Start Date: June 10, 2015
    Location: Namacurra, Zambezia, Mozambique
    Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

    The overall goal of this project is to adapt and assess the impact of a traditional healer training program/intervention on the adherence, retention, and viral load of HIV infected patients newly initiated on anti-retroviral therapy (ART) in rural Mozambique.

  • Fostering Resilience to Psychosocial and HIV Risk in Indian MSM
    Study Type: Interventional
    Start Date: June 1, 2015
    Locations: Chennai, India; Mumbai, India
    Eligibility: Males, Ages 18 and Older, Accepts Healthy Volunteers

    India has the world's third largest HIV epidemic and men who have sex with men (MSM) are an identified high risk group. MSM in India face unique psychosocial stress underlying the context of HIV risk. To maximize the potential impact of an HIV prevention intervention, the purpose of this study is to test, in a two-arm randomized controlled efficacy trial, a behavioral intervention that addresses both psychosocial / contextual stress and reducing participant's risk for HIV.

  • Analysis of Telmisartan Administered With Antiretroviral Therapy (ART) in Patients With Acute HIV Infection
    Study Type: Interventional
    Start Date: August 1, 2014
    Location: Bangkok, Thailand
    Eligibility: Ages 18 and Older, Does Not Accept Healthy Volunteers

    This research project will study whether the drug telmisartan administered in conjunction with antiretroviral therapy (ART) will help reduce nervous system infection with HIV. The investigators are studying the effect of this treatment in people who have contracted HIV infection within the past three weeks, and thus have a form of HIV called acute HIV infection. The investigators will measure biological markers of immune activation in the blood and cerebrospinal fluid to see if telmisartan may reduce the spread of HIV reservoirs in affected patients.

  • Adolescent Master Protocol for Participants 18 Years of Age and Older (AMP Up)
    Study Type: Observational
    Start Date: April 1, 2014
    Locations: La Jolla, California; Aurora, Colorado; Fort Lauderdale, Florida; Miami, Florida; Chicago, Illinois; New Orleans, Louisiana; Boston, Massachusetts; Newark, New Jersey; Bronx, New York; Philadelphia, Pennsylvania; Memphis, Tennessee; Houston, Texas; San Juan, Puerto Rico
    Eligibility: Ages 18 and Older, Accepts Healthy Volunteers

    This is a prospective cohort study designed to define the impact of HIV infection and antiretroviral therapy (ART) on young adults with perinatal HIV infection as they transition into adulthood. A group of perinatally HIV-exposed, -uninfected (PHEU) young adults from a similar sociodemographic background and age distribution will be enrolled for comparison.

  • Observational Study of HIV-associated Neurocognitive Disorder
    Study Type: Observational
    Start Date: October 1, 2013
    Location: Atlanta, Georgia
    Eligibility: Ages 18–59, Does Not Accept Healthy Volunteers

    It is estimated that over 1 million people in the United States have HIV infection. While HIV is treatable, there are still high rates of HIV-associated neurocognitive disorder (HAND). HAND is defined by low scores on memory testing. To meet the criteria for HAND, an HIV-infected individual has to have a low score on at least two different memory tests. It is estimated that 20-50% of people living with HIV have HAND. It is therefore still a common problem. While individuals with HAND typically improve on antiretroviral therapy for HIV, often this improvement is incomplete. Also, there are over 20 antiretroviral medications approved for HIV in the US. It is not clear if the specific choice of antiretroviral medication makes a difference in the improvement of HAND.

    The investigators have designed a small preliminary study in which subjects with and without HAND who have never been on treatment for HIV or have been off treatment for at least 6 months are followed for the first 12 months after starting antiretroviral therapy.The investigators will enroll a maximum of 46 subjects (23 subjects in each arm). Subjects will also be followed by their primary HIV medical provider. For the study, subjects will be followed for 48 weeks. There are three followup visits: 12 weeks, 24 weeks, and 48 weeks. Memory testing will be performed at baseline and each followup visit. Blood will also be taken at baseline and the three followup visits to measure changes in inflammation. A lumbar puncture will be performed at baseline and at 24 weeks to measure changes in inflammation and amount of HIV virus in the spinal fluid. There is also an optional lumbar puncture at the last study visit of 48 weeks

  • Intervention to Improve Engagement in Care Among Newly Diagnosed HIV-positive Men
    Study Type: Interventional
    Start Date: November 1, 2012
    Location: New York, New York
    Eligibility: Males, Ages 18 and Older, Does Not Accept Healthy Volunteers

    The study involves delivering one of two interventions - either Promoting Action Towards Health (PATH) or Personalized Cognitive Counseling (PCC) - to 440 men who have sex with men (MSM) who have recently been diagnosed with HIV and assessing whether participants who received PATH achieve greater suppression of HIV viral load, demonstrate greater uptake of care and adherence to treatment, and engage in less sexual HIV transmission risk behavior than participants who received PCC.

    - PATH consists of two preliminary sessions plus "booster" sessions after 1, 3, and 6 months.

    - Personalized Cognitive Counseling consists of one session.

    Participants will complete assessments before participating in their intervention (i.e., at "baseline") and at 3, 6, 9, and 12 month follow-up points. Participants' viral loads will be measured at approximately 6 and 12 months following baseline.

  • Safer Sex Program for Young African-American Men
    Study Type: Interventional
    Start Date: September 1, 2012
    Location: Jackson, Mississippi
    Eligibility: Males, Ages 15–29, Accepts Healthy Volunteers

    To evaluate the efficacy of the adapted program a randomized controlled trial enrolling 620 eligible African American men who have sex with men (MSM) will be conducted. Men in the treatment condition will be compared to men receiving the control condition comprised of standard of care counseling from the clinic plus a free bag of condoms and water-based lubricants. This two-arm trial will test four hypotheses:

    Aim: To test the efficacy of a brief, clinic-based and theory-guided, intervention designed to reduce STD incidence and risk of HIV acquisition/transmission among young African American men (15-29 years old) having sex with men and presenting for STD testing.

    H1. Men randomized to receive the intervention will have a lower incidence rate of laboratory-confirmed STDs at each of three follow-up assessments compared to those receiving the control condition.

    H2. Men randomized to receive the intervention will report significantly fewer acts of unprotected penetrative sex (penile-vaginal or penile-anal) between follow-up assessments compared to those receiving the control condition.

    H3. Men randomized to receive the intervention will report having significantly fewer unprotected penetrative sex partners (for penile-vaginal or penile-anal sex) between follow-up assessments compared to those receiving the control condition.

    H4. Men randomized to receive the intervention will report having significantly fewer negative experiences with condom use between follow-up assessments compared to those receiving the control condition.

    H5. Men randomized to receive the intervention will demonstrate significantly greater improvement in condom application skills, throughout the 12-month study, compared to those receiving the control condition.

  • Eban II: Intervention for HIV Sero-Discordant Couples
    Study Type: Interventional
    Start Date: July 1, 2012
    Location: Oakland, California
    Eligibility: Ages 18–60, Accepts Healthy Volunteers

    This study focuses on the implementation of an evidence-based HIV risk reduction intervention for HIV-serodiscordant, heterosexual African American couples ("Eban II") in two geographic areas (Northern and Southern California - roughly, Alameda and Los Angeles Counties) that have a high prevalence of HIV infection and risk conditions among African Americans.

    The Specific Aims are as follows:

    1. To evaluate implementation of Eban for HIV serodiscordant African American couples in 10 CBOs in California. To do this, we will document the implementation process and identify barriers and facilitators to Eban's adoption and use by the CBOs. We will interview 200 staff at CBOs to obtain this information.

    2. To evaluate the effect of Eban on behavioral and biological outcomes among 180 couples, specifically incidents of protected sex, proportion of condom use, and incident sexually transmitted infections. Eban will be assessed using a randomized delayed enrollment (waitlist) control design to evaluate the impact of treatment on outcomes at posttest and 3-month follow-up (i.e., at these 10 CBOs, Eban will be conducted and offered to couples and evaluated for effectiveness - that is, how well it works in the real world.)

    3. To determine the cost-effectiveness of implementation of Eban, based on implementation costs and potential cost savings.