HIV Study Registry

Studies enrolling adults

• PMHARC Cohort Assessment

• Phase 1 trial testing three-antibody combination for HIV prevention – HVTN141

• Phase 1 HIV vaccine trial – HVTN 322

• Kidney Transplantation from Donors with HIV: Impact on Rejection and Long-Term Outcomes

• Neurometabolic profile of smokers with HIV

• Neurometabolic profile of marijuana users with HIV

• Evaluating the HIV reservoir of the placenta of pregnant women with HIV

• A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research: Improving Tobacco Treatment Rates for People Living with HIV Who Smoke

• The Effects of a Transitional Housing Program on Health, Economic, and Psychologic Outcomes Among People with HIV

• Menopausal Hormone Therapy for Women with HIV (HoT) – A5424

• “COPE” Study – A5402

• T-Cell Vaccine, bNAbs, & VES –  A5374

• Optimizing Tobacco Use Treatment for PLWH

• Suppressed Acute HIV – A5374

• Weekly ART – Mk-8591b-062

Studies enrolling youth

• Developing and pilot testing an eHealth decision support tool for young people at risk of HIV to improve informed decision making about PrEP

• Neurometabolic profile of infants exposed to HIV but uninfected

• Clinical and Implementation Outcomes of a Point of Care Sexually Transmitted Infection Testing Strategy to Improve HIV Prevention Service Delivery in Adolescents

• Screen2Prevent

• ScreenSmart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department

Studies enrolling globally

• Breastmilk Immunology Study

• Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap from Cervical Cancer Diagnosis to Treatment in Botswana

• A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women with HIV in Botswana

Studies enrolling adults

Phase 1 HIV vaccine trial – HVTN 322

• Full title: A phase 1 clinical trial to evaluate the safety and immunogenicity of the V2 apex–directed immunogens DV201P-RNA and DV202B1-RNA in adult participants without HIV
• Objective: This is a 6-16 month study testing the safety and effectiveness of two different medications designed to induce creation of antibodies against HIV.
• Inclusion criteria: Adults aged 18-55 living without HIV, who have not participated in an HIV vaccine or antibody study before.
• Interventional
• Inclusion criteria: Adults aged 18-55 living without HIV, who have not participated in an HIV vaccine or antibody study before.
• Enrollment sites: Penn Prevention (3535 Market St. Floor 4)
• Participant compensation: Study participation will last 6-16 months. There will be 8-14 visits across the study period. Compensation will be approximately $900-$2000. Study length, visit count, and compensation depend on treatment group.
• PI: Ian Frank
• Study contact: Sirisha Krishnamurthy (sirisha.krishnamurthy@pennmedicine.upenn.edu, call or text 302-729-8303)

Kidney Transplantation from Donors with HIV: Impact on Rejection and Long-Term Outcomes

• Objective: The primary objective is to quantify the association, if any, between donor HIV status and risk of rejection in kidney transplant recipients with The secondary objective is to determine long-term outcomes  of D+ and D- kidney transplant in HIV+ recipients.
• Non-Interventional
• Inclusion criteria:
  • Meets local criteria for kidney transplant
  • Documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA
  • HIV-1 RNA < 50 copies/mL
• Enrollment sites: PCAM ID Clinic
• No participant compensation
• PI: Dr. Emily Blumberg
• Study contact: Maryann Najdzinowicz (maryann.najdzinowicz@pennmedicine.upenn.edu, 215-662-4007)

Neurometabolic profile of smokers with HIV

• Objective: To evaluate impact of tobacco smoking on brain chemistry of individuals with or without HIV. We are recruiting both HIV+ smokers/nonsmokers and HIV- smokers and/nonsmokers
• Non-Interventional
• Inclusion criteria:
  • Smoker (daily smoker for past 30 days) OR Non-smoker (has not smoked for the last 6 months)
  • HIV negative OR HIV positive with VL <1000 copies/ml confirmed by self report
• Enrollment sites: CHOP
• Participant compensation provided
• PI: Dr. Muhammad Saleh
• Study contact: brainspec@chop.edu, (267) 425-9610

Neurometabolic profile of marijuana users with HIV

• Objective: To evaluate the impact of marijuana smoking or edibles on brain chemistry of individuals with HIV
• Non-Interventional
• Inclusion criteria:
  • Marijuana smokers (smoke marijuana at least 2 days per week for the past 60 days) OR marijuana edible takers – taking (e.g., drinking, eating, pills, or tinctures) edibles at least 2 days per week for the past 60 days
  • HIV+ with VL <1000 copies/ml confirmed by self report
• Enrollment sites: CHOP
• Participant compensation: Compensation is $150 after completing the study visit
• PI: Dr. Muhammad Saleh
• Study contact: brainspec@chop.edu, (267) 425-9610

Evaluating the HIV reservoir of the placenta of pregnant women with HIV

• Objective: This prospective study will evaluate the transcriptional profile and proviral landscape of HIV at the maternal-fetal interface. We hypothesize that the placenta is an active HIV reservoir, with both intact HIV provirus and matured HIV transcripts present in immune cells and non-immune cells.
• Non-Interventional
• Inclusion criteria:
  • Age ≥ 18 years old
  • Confirmed to be living with HIV by lab diagnostic test
  • Confirmed to be pregnant by lab diagnostic test/ultrasound
  • Receiving care at or volunteering for HIV-related studies at one of the specified Penn-affiliated hospitals
  • Receiving prenatal care at one of the specified Penn-affiliated hospitals
  • Willingness to sign an informed consent form and donate placental specimens
• Enrollment sites: PCAM ID Clinic, Presbyterian ID Clinic
• PI: Dr. William Short
• Study contacts: Katharine J Bar (bark@pennmedicine.upenn.edu) and Jake Robinson (jake.robinson@pennmedicine.upenn.edu)

A Patient-Oriented Research Mentoring Program in Tobacco Dependence and Implementation Science Research: Improving Tobacco Treatment Rates for People Living with HIV Who Smoke

• Objective: In this study we will conduct a four-arm pragmatic cluster RCT to test the effectiveness of nudges to clinicians, nudges to patients, or nudges to both in increasing TUTS referral and engagement in HIV patients who smoke, vs. usual care.
• Non-Interventional
• Inclusion criteria: Patients of participating clinicians who have a diagnosis of HIV and have record of smoking in their EHR.
• No compensation provided
• Enrollment sites: Hospital of the University of Pennsylvania (HUP), Penn Presbyterian Medical Center (PPMC)
• PI: Dr. Robert Schnoll
• Study contacts: Casey Foster (casey.foster@pennmedicine.upenn.edu, 215-756-8432) and Robert Schnoll (schnoll@pennmedicine.upenn.edu, 215-746-7143)
• Note: This study is not open for recruitment from the general public since participants are found from Penn’s EHR.

The Effects of a Transitional Housing Program on Health, Economic, and Psychologic Outcomes Among People with HIV

• Objective: To evaluate the implementation and effectiveness (health, economic, and psychological outcomes) of a new transitional housing program for people living with HIV in Philadelphia (Arms Around You program)
• Non-Interventional
• Inclusion criteria: On the waitlist for the Arms Around You program. To apply for the program, applicants must be Philadelphia residents, HIV positive, and unhoused or unstably housed
• Enrollment sites: Enrollment completed over the phone; study housed at Penn Medicine
• PI: Dr. Aaron Richterman
• Study contact: Charlotte Babbin (charlotte.babbin@pennmedicine.upenn.edu, (215) 573-9219)

Menopausal Hormone Therapy for Women with HIV (HoT) – A5424

• Objective: The purpose of this study is to see if hormone therapy (oral progesterone and transdermal estradiol) helps reduce hot flashes and night sweats, in women living with HIV in the late menopausal transition or early post-menopause. Participation lasts 5 months. There is a significant lack of historical research in this specific population; a population in which vasomotor symptoms have been shown to be more severe.
• Interventional
• Inclusion criteria:
  • Living with HIV
  • Assigned female at birth
  • Age 40-60
  • In late menopausal transition or early post menopause
  • Self-report of an average of 2 or more moderate or severe menopausal VMS (i.e., hot flashes or night sweats) per day
  • Currently receiving ART, and on ART for more than 1 year prior
• Enrollment sites: PCAM ID Clinic and Presbyterian ID Clinic
• Participants are compensated
• PI: Dr. William Short
• Study contact: Kelly Wall (Kelly.Wall@Pennmedicine.upenn.edu, 215-349-8092)
• More info here

“COPE” Study – A5402

• Full title: An Open-Label, Randomized Controlled Trial of Pramipexole versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD with Mild Neurocognitive Disorder (MND) in Persons with HIV
• Objective: The A5402 study (COPE) is a 24-week research study designed for people living with HIV who are experiencing depression and, in some cases, mild memory or thinking problems. The goal of the study is to see which of two FDA-approved medications (Pramipexole versus Escitalopram) are safer and more effective at treating these symptoms in people with HIV. 
• Interventional
• Inclusion criteria: HIV+ patients who are experiencing depression symptoms, but are not currently taking antidepressants (it’s ok if they have in the past)
• Enrollment sites: PCAM ID Clinic and Presbyterian ID Clinic
• Participants are compensated
• PI: Dr. William Short
• Study contact: Zenia Lauw (zenia.lauw@pennmedicine.upenn.edu, 215-349-8092)
• More info here

T-Cell Vaccine, bNAbs, & VES –  A5374

• Full title: A Phase I/IIa Randomized, Placebo-Controlled Trial of Conserved-Mosaic T-cell Vaccine in a Regimen with Vesatolimod and Broadly Neutralizing Antibodies in Adults Initiated on Suppressive Antiretroviral Therapy during Acute HIV-1
• Objective: A5374 is recruiting patients who were diagnosed and started ART during Acute HIV infection. During the study, they will be given a combination of a T-Cell vaccine, Vesatolimod, and Broadly Neutralizing Antibodies to see if the combination of these products improves the body’s response to HIV in people with HIV who started ART early after infection.
• Interventional
• Inclusion criteria: Individuals living with HIV-1 who initiated ART during acute infection and have maintained viral suppression since ART initiation and for at least 1 year.
• Enrollment sites: PCAM ID Clinic and Presbyterian ID Clinic
• Participants are compensated
• PI: Dr. Pablo Tebas
• Study contact: Chungdhak Tsang (Chungdhak.Tsang@Pennmedicine.upenn.edu, (215) 349-8092)

Optimizing Tobacco Use Treatment for PLWH

• Full title: Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers with HIV
• Objective: Test whether pharmacogenetic tailoring (nicotine patch or varenicline) and adherence support paired with standard counseling improve smoking cessation compared to varenicline and counseling alone.
• Interventional
• Inclusion criteria: HIV+, Virally suppressed (<1000 copies/ml), Daily smoker
• Enrollment sites: PCAM ID clinic, Presbyterian ID clinic, CHOP, VA, FIGHT, Jefferson, Colours, anywhere HIV+ smokers in care can be offered participation.
• Participants are compensated
• PI: Dr. Robert Gross
• Study contact: Casey Foster (casey.foster@pennmedicine.upenn.edu, 215-746-2715)
• Note: Everyone gets gold standard smoking cessation support and free drug as well as compensation. The counseling staff have extensive experience with and sensitivity toward the HIV+ community.

Suppressed Acute HIV – A5374

• Full title: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial of Combination HIV-Specific Broadly Neutralizing Monoclonal Antibodies Combined with ART Initiation during Acute HIV Infection to Induce HIV Remission
• Objective: Participants will receive Biktarvy through the study and be randomized to also receive either a broadly neutralizing antibody (bNAB) infusion or placebo, to see if starting the bNAB during actue infection can improve the body’s ability to fight HIV.
• Interventional
• Inclusion criteria: Patients who have just been diagnosed with Acute HIV Infection and have not yet started on ART
• Enrollment sites: PCAM ID clinic, Presbyterian ID clinic
• Participants are compensated
• PI: Dr. Pablo Tebas
• Study contact: Thomas Shen (Thomas.Shen@PennMedicine.upenn.edu, (215) 349-8092)

Weekly ART – Mk-8591b-062

• Full title: A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Nave Adult Participants Living With HIV-1
• Objective: Mk-8591b-062 is recruiting During the study participants will be randomized to receive either Islatravir/Ulonaivirine (ISL/ULO, investigational once weekly pill) Biktarvy (standard of care once daily pill) to see if ISL/ULO is as effective as current ART options.
• Interventional
• Inclusion criteria: Patients who are living with HIV but have not yet started ART.
• Enrollment sites: PCAM ID clinic, Presbyterian ID clinic
• Participants are compensated
• PI: Dr. Pablo Tebas
• Study contact: Thomas Shen (Thomas.Shen@PennMedicine.upenn.edu, (215) 349-8092)
• Learn more here

Studies enrolling youth

Developing and pilot testing an eHealth decision support tool for young people at risk of HIV to improve informed decision making about PrEP.

• Objective: Formative surveys to assess PrEP perceptions in trans femme women between the ages of 15 and 24.  
• Non-Interventional
• Inclusion criteria:
  • 15-24 years old
  • Identifies as a trans woman
  • Reports being HIV negative
  • Minors who can consent for themselves
• Participation is virtual
• Participant compensation: $25 for completing the survey
• PI: Dr. Sarah Bauerle Bass (Temple) and Dr. Marne Castillo (CHOP)
• Study contact: Bevin Gwiadowski (gwiazdowsb@chop.edu, 215-840-6813)

Neurometabolic profile of infants exposed to HIV but uninfected

• Objective: To evaluate the impact of HIV exposure and cART in utero
• Non-Interventional
• Inclusion criteria: Infants (age 0-4 months) exposed to HIV but uninfected
• Compensation of $250
• Enrollment sites: CHOP
• PI: Dr. Muhammad Saleh
• Study contact: Funmi Aka-Bashoru (akabashorf@chop.edu, 267-425-9630)

Clinical and Implementation Outcomes of a Point of Care Sexually Transmitted Infection Testing Strategy to Improve HIV Prevention Service Delivery in Adolescents

• Objective: To test the overarching hypothesis that gonorrhea and chlamydia point of care testing (GC/CT POCT) will improve HIV testing, PrEP counseling, and PrEP delivery, and be a feasible, acceptable, and appropriate implementation strategy in adolescents seeking STI testing in three Philadelphia pediatric settings.
• Non-Interventional
• Inclusion criteria: 16-24 years who have received POCT or lab-based GC/CT testing across three CHOP adolescent health clinics, excluding patients living with HIV or taking PrEP.
• Enrollment sites: CHOP
• Participants are compensated
• PI and Study contact: Nadia Dowshen (dowshenn@chop.edu; 267-426-2591)

Screen2Prevent

• Objective: #1 Propose a clinically effective, cost-effective, and sustainable Emergency Department (ED) based HIV screening, prevention, and treatment model that can be scaled and integrated across other EDs.
• Interventional
• Inclusion criteria:
  • EMR abstraction eligible if:
    • Presents to ED during 24-month study period
    • Presents to ED during 12-month period preceding start of study activities
    • Aged 14-24 years
  • Survey eligible if:
    • Presents to ED during 24-month study period
    • Aged 14-24 years
• Enrollment sites: Five participating site consortium of the Adolescent Medical Trials Network (ATN): (1) University of South Florida, Tampa, FL, (2) Johns Hopkins University, Baltimore, MD, (3) St. Jude Children’s Hospital, Memphis, TN, (4) Emory Healthcare, Atlanta, GA, and (5) Texas Children’s, Houston, TX
• PI and study contact: Nadia Dowshen (dowshenn@chop.edu; 267-426-2591)
• More info here

ScreenSmart: Using Digital Health to Improve HIV Screening and Prevention for Adolescents in the Emergency Department

• Objective: To adapt a computerized screening intervention for broad-scale HIV screening, specifically addressing the national End the HIV Epidemic (EHE) diagnosis and prevention pillars to:
  • 1) increase HIV screening rates in pediatric EDs,
  • 2) use computer-facilitated collection of patient-reported outcomes to confidentially and efficiently assess PrEP candidacy, and
  • 3) leverage mHealth to improve linkage to care for HIV prevention and treatment.
• Interventional
• Inclusion criteria: Youth ages of 14 and 21 presenting to emergency department
• Enrollment sites: CHOP, Nationwide Children’s Hospital, Children’s Wisconsin – Milwaukee.
• Participants are not compensated
• PI and study contact: Dr. Nadia Dowshen (dowshenn@chop.edu; 267-426-2591)
• More info here

Studies recruiting globally

Breastmilk Immunology Study

• Full title: In-depth characterization of myeloid cells in human milk from HIV- and HIV+ donors as potential vehicles of and defenders against vertical transmission of HIV: essential data for targeted therapeutics
• Objective: This project aims to fully classify myeloid cells in human milk and investigate their role in facilitating and preventing transmission of HIV.
• Non-Interventional
• Inclusion criteria: This study is enrolling women with and without HIV who are lactating
• Enrollment sites: All enrollment in Botswana
• Participants are compensated
• PI: Rebecca Powell, PhD (ICahn School of Medicine at Mt. Sinai)
• Study contact: Liz Lowenthal (CHOP), lowenthale@chop.edu,  267-426-2306

Thibang Diphatlha: Testing Adaptive Strategies to Close the Gap from Cervical Cancer Diagnosis to Treatment in Botswana

• Objective: This study is testing the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in Botswana using a hybrid (type III) and pragmatic Sequential Multiple Assignment Randomized Trial (SMART) design.
• Interventional
• Inclusion criteria:
  • Biological females
  • Aged 18 or older
  • Have pathology-confirmed invasive cervical cancer diagnosis
  • Have pathology results evaluated at the National Health Laboratory in Botswana
  • Are citizens of Botswana
  • Have no prior history of invasive cervical cancer
• Enrollment sites: All enrollment in Botswana
• PI: Dr. Katharine Rendle and Dr. Surbhi Grover
• Study contact: Jocelyn Wainwright; jocelyn.wainwright@pennmedicine.upenn.edu; (215) 964-2631

A Pilot Trial of an Unconditional Cash Transfer for Pregnant Women with HIV in Botswana

• Objective: In this randomized controlled trial of monthly payments to pregnant women in Botswana, we ask if the cash transfer: 1) improves mental bandwidth  2) improves ART adherence during pregnancy and postpartum.  The study also looks at implementation barriers and facilitators.
• Interventional
• Inclusion criteria:
  • Age 18+
  • Botswana citizen
  • Seeking/receiving antenatal care
  • HIV positive
  • In second trimester
  • Low income (<14,000 Botswana Pula per year)
• Enrollment sites: Enrollment sites: All enrollment in Botswana
• PI: Dr. Aaron Richterman
• Study contact: Charlotte Babbin (research coordinator), charlotte.babbin@pennmedicine.upenn.edu