Studies

Below are current and completed studies as a part of the UNC Project-Malawi. Studies are collaborations between different research institutions and are listed below accompanied by UNC Based Investigators.

HIV Prevention

MTN 020: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase 3 Safety and Effectiveness Trial of a Vaginal Matrix Ring Containing Dapivirine for the Prevention of HIV-1 Infection in Women
Irving Hoffman

MTN-015:  An Observational Cohort Study of Women Following HIV-1 Seroconversion in Microbicide Trials
Irving Hoffman 

HPTN 052: A Randomized Trial to Evaluate the Effectiveness of Antiretroviral Therapy Plus HIV Primary Care Versus HIV Primary Care Alone to Prevent the Sexual Transmission of HIV-1 in Serodiscordant Couples
Mina Hosseinipour 

HVTN 111: A phase 1 clinical trial to evaluate the safety and immunogenicity of HIV Clade C DNA and of MF59-Adjuvanted Clade C Env protein, in healthy, HIV-uninfected adult participants.
Mina Hosseinipour 

Completed Studies:
Partner Notification Study:
Examined efficacy, cost effectiveness, and social acceptability of three different methods of partner notification (passive referral, contact referral, or provider referral).
Irving Hoffman  

MP3 Study - Acute HIV Infection - A Key Link for Transmission Prevention.  Piloted an aggressive HIV transmission prevention program to identify persons with acute HIV and intervene behaviorally and biologically.
Bill Miller 

HPTN 035: Phase I/IIB Safety and Effectiveness Study of the Vaginal Microbicides Buffer Gel and 0.5% PRO 2000/5 Gel (P) for the Prevention of HIV Infection in Women
Irving Hoffman, Francis Martinson 

CHAVI 001: A multi-year observational study delineating host immune responses to acute HIV-1 infection.
Irving Hoffman, Francis Martinson 

Prevention of Mother to Child Transmission

IMPAACT 1077BF: The PROMISE Study (Promoting Maternal and Infant Survival Everywhere). Investigating optimal interventions for prevention of antepartum and intrapartum HIV transmission, prevention of postpartum transmission in breastfeeding infants, and the optimal intervention for the preservation of maternal health after the risk period for MTCT has ended.
Francis Martinson 

IMPAACT P1084s: The PROMISE Study (Promoting Maternal and Infant Survival Everywhere). A 1077BF substudy evaluating the effect of tenofovir exposure during pregnancy or breast feeding on bone, renal, and growth outcomes.
Francis Martinson 

The PURE Study: Improving uptake and retention in PMTCT services through novel approaches in family supported care and in community peer outreach support in Malawi
Mina Hosseinipour, Sam Phiri, Nora Rosenberg, Innocent Mofolo 

Completed Studies: 
The BAN Study
: HIV Infection and Breastfeeding: Interventions for Maternal and Infant Health.  Evaluated the efficacy of extended antiretroviral treatment, a nutritional intervention, and exclusive breastfeeding in 2370 women and their infants.
Charles van der Horst  

HIV Treatment and Co-infection (Adult)

A5263/AMC 066 - A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings
Mina Hosseinipour, Agnes Moses 

A5264/AMC067 - A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS)
Mina Hosseinipour, Agnes Moses, Satish Gopal  

A5279: A Phase III Clinical Trial of Ultra-Short Course Rifapentine/Isoniazid for the Prevention of Active Tuberculosis in HIV Infected Individuals withLatent Tuberculosis Infection
Mina Hosseinipour, Cecilia Kanyama 

A5288 MULTI-OCTAVE - Management Using the Latest Technologies in Resource-limited Settings to Optimize Combination Therapy After Viral Failure
Mina Hosseinipour, Cecilia Kanyama 

A5273: Multicenter Study of Options for Second-Line Effective Combination Therapy, (SELECT Study)
Mina Hosseinipour, Cecilia Kanyama 

A5274 Remember: Reducing Early Mortality and Early Morbidity by Empiric Tuberculosis Treatment Regimens
Mina Hosseinipour, Agnes Moses  

ACTA Study: A Phase III, Randomised, Controlled Trial for the Treatment of HIV Associated Cryptococcal Meningitis: Oral Fluconazole Plus Flucytosine or one  Week Amphotericin B-Based Thrapy vs Two Weeks Amphotericin B-Based Therapy
Tom Harrison, Mina Hosseinipour, Cecilia Kanyama 

Completed Studies:
A5175:
A Phase IV, Prospective, Randomized, Open-Label Evaluation of the Efficacy of Once-Daily Protease Inhibitor and Once-Daily Non-Nucleoside Reverse Transcriptase Inhibitor-Containing Combinations for Initial Treatment of HIV-1 Infected Individuals from Resource-Limited Settings (PEARLS) Trial
Joseph Eron, Mina Hosseinipour 

A5208/ OCTANE: Optimal Combination Therapy After Nevirapine Exposure
Mina Hosseinipour, Cecilia Kanyama  

A5221 - STRIDE: A Strategy Study of Immediate Versus Deferred Initiation of Antiretroviral Therapy for AIDS Disease Free Survival in HIV Infected Persons Treated for Tuberculosis with CD4 < 250 Cells/mm

A5230: A Pilot Study of Lopinavir/Ritonavir in Participants Experiencing Virologic Relapse on NNRTI-Containing Regimens

A5253 - Sensitivity and Specificity of Mycobacterium Tuberculosis Screening and Diagnosis in HIV-Infected Individuals

HIV Treatment and Co-infection (Pediatric)

IMPAACT P1104s: Longitudinal Developmental and Neuropsychological Assessments of HIV-Infected Participants of P1060 and HIV-Uninfected Controls
Mina Hosseinipour, Portia Kamthunzi 

IMPAACT P1060 - Phase III, Parallel, Randomized, Clinical Trials Comparing the Responses to Initiation of NNRTI-Based Versus PI-Based Antiretroviral Therapy in HIV-Infected Infants Who Have and Have Not Previously Received Single Dose Nevirapine for Prevention of Mother-to-Child HIV Transmission
Irving Hoffman, Portia Kamthunzi 

Completed Studies:
IMPAACT P1079:
Pharmacology Of Artemisinin-Based Antimalarial Therapy Within The Context Of Antiretroviral Therapy
Mina Hosseinipour, Portia Kamthunzi 

A5190: Assessment of Safety and Toxicity Among Infants Born to HIV-Infected Women Enrolled in Antiretroviral Treatment Protocols in Diverse Areas of the World (A5190/P1054)
Mina Hosseinipour, Portia Kamthunzi 

 

Cancer

LCCC 1229: Developing a prospective lymphoma clinical cohort in Malawi
Satish Gopal 

Secondary analysis of cancers at KCH: The KCH Cancer and Pathology Registry
Mina Hosseinipour, George Liomba, Satish Gopal 

UNCPM 1309: Enhancing Breast Cancer Early Detection in Malawi
Racquel Kelly Kohler 

A5263/AMC 066: A Randomized Comparison of Three Regimens of Chemotherapy with Compatible Antiretroviral Therapy for Treatment of Advanced AIDS-KS in Resource-Limited Settings (also listed under HIV Treatment above)
Mina Hosseinipour, Agnes Moses 

A5264/AMC067: A Randomized Evaluation of Antiretroviral Therapy Alone or with Delayed Chemotherapy versus Antiretroviral Therapy with Immediate Adjunctive Chemotherapy for Treatment of Limited Stage AIDS-KS in Resource-Limited Settings (REACT-KS) (also listed under HIV Treatment above)
Mina Hosseinipour, Agnes Moses, Satish Gopal

 A5282A Randomized Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-based Strategy for Prevention of CIN 2+ in HIV-infected Women.
Mina Hosseinipour, Agnes Moses, Jeff Stringer, Thandie Lungu 

Completed Studies:
UNCPM 1305: 
Analysis of genes whose proteins are the targets of specific chemotherapy agents in esophageal cancer at Kamuzu Central Hospital
Carol Shores  

CID 1207Utility of bone marrow examination in resource-limited environment 
Mini Hosseinipour 

Malaria

Completed Studies:
Malaria-055 (110021): A Phase III, Double-blind (Observer-blind), Randomized, Controlled Multi-center Study to Evaluate, in Infants and Children, the Efficacy of the RTS,S/AS01E Candidate Vaccine against Malaria Disease caused by P. falciparum Infection, Across Diverse Malaria Transmission Settings in Africa
Irving Hoffman, Francis Martinson        

EPI MAL - 001: An epidemiology study to assess Plasmodium falciparum parasite prevalence and serological conversion rates in catchment areas of a Phase III trial of the candidate malaria vaccine RTS,S/AS01E in sub-Saharan Africa
Irving Hoffman, Francis Martinson 

IMPAACT P1079: Pharmacology Of Artemisinin-Based Antimalarial Therapy Within The Context Of Antiretroviral Therapy (Also listed under HIV Treament)
Mina Hosseinipour, Portia Kamthunzi 

CID 1228: Understanding the Prevalence and Population Structure of Plasmodium falciparum in Lilongwe, Malawi
Jonathan Juliano 

CID-0920: Massively Parallel Pyrosequencing to Define the Diversity of Malaria in Vaccine Trials
Jonathan Juliano 

Surgery

Best Method of Burn Wound Care: A Prospective Randomized Trial
Anthony Charles, Jared Gallaher 

Use of disposable spirometer for recovery of pulmonary function following exploratory laparotomy
Anthony Charles 

Women's Health

Obstetric Fistula

CID 1116: Assessment of conditions surrounding fistula formation and successful repair in Bwaila Hospital, Lilongwe
Jeff Wilkinson 

UNC PM 1302: Long-term outcomes for women after obstetric fistula repair: a qualitative study
Jeff Wilkinson, Jennifer Tang 

Completed Studies: 
ACOG Study:
Ultrasonographic and laboratory assessment of women with obstetric fistula
Jeff Wilkinson  

Obstetric Fistula

UNC PM 1310: Integration of Family Planning into the Safe Motherhood Initiative in Malawi
Jennifer Tang 

Completed Studies: 
CID 0925:
A pilot study of a randomized trial comparing two different time frames for Copper T380A intrauterine contraception insertion; immediately postpartum compared to 4-6 weeks postpartum in Lilongwe, Malawi
Gretchen Stuart, Amy Bryant 

CID 092812/30/2014  Review of Contraceptive Counseling and Contraceptive Access at Family Planning Clinics in Lilongwe, Malawi
Gloria Hamela  

CID 0929: Prospective Assessment of Acceptability and Adherence Associated with Use of the Copper Intrauterine Device (CuT380A-IUCD) compared to Depo-medroxyprogesterone acetate (DMPA) among HIV Positive Women in Lilongwe, Malawi
Gretchen Stuart, Lisa Haddad 

Cancer

UNCPM 1309: Enhancing Breast Cancer Early Detection in Malawi (Also listed under Cancer above).
Racquel Kelly Kohler 

A5282: A Randomized Trial to Compare an HPV Test-and-Treat Strategy to a Cytology-based Strategy for Prevention of CIN 2+ in HIV-infected Women (Also listed under Cancer above). 
Mina Hosseinipour, Jeff Stringer, Agnes Moses, Thandie Lungu 

Other

UNC PM 1312: Alcohol use disorders and HIV spectrum of care among female sex workers in Malawi
Mina Hosseinipour 

Health Systems Strengthening 

Supporting the implementation of guidelines to prevent mother-to-child transmission of HIV in Malawi: A qualitative descriptive case-study
Chifundo Zimba

Completed Studies:
Case Study Assessment of Integrated Health Services in Malawi (Measure protocol)
Elizabeth Sutherland, Innocent Mofolo 

How Best Can HIV/AIDS Policy be Moved to Successful Implementation? Lessons from Routine HIV Testing of Patients with Sexually Transmitted Infections in Malawi 
Gift Kamanga  

Diagnostics 

Exploring the role and accuracy of the GeneXpert in tuberculosis diagnosis and drug resistance screening in Malawi
Irving Hoffman, Mina Hosseinipour, Tar Chikaonda 

Introducing Diagnostic Methods for Sickle Cell Disease in Malawi
Satish Gopal, Brett Heimlich  

Completed Studies:
An evaluation of use of dried blood spot specimens for viral load monitoring of antiretroviral therapy in Malawi
Sarah Rutstein 

CID 0916: The Bwaila/Kamuzu Central Hospital In-Patient Tuberculosis Ward: A Feasibility Study to Introduce Additional Diagnostic Tests and Characterize the Retreatment Patient Population
Dan Namarika, Charles Vorkas