HIV-1 Resistance at Screening for HIV Prevention Studies

Prevalence of HIV-1 Drug Resistance Within a Female Screening Population for HIV Prevention Trials

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials.

Study Overview

• Status: Completed
• Conditions: HIV

Detailed Description

MTN-009 is a multi-site, cross-sectional study that will provide an estimate of the prevalence of ARV resistance in the population of women who present to study sites to be pre-screened or screened for participation in an HIV prevention trial. To date, a comprehensive surveillance of HIV drug resistance in newly diagnosed women of reproductive age has yet to be undertaken. The primary goal of MTN-009 is to assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials. Secondary aims include the identification and evaluation of behavioral indicators including self or sexual partner(s) exposures to antiretroviral (ARV) drugs as risk factors for drug resistant HIV infection, as well as the characterization of the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting to screen for participation in an HIV prevention trial. Exploratory aims include the identification of polymorphic or subtype-specific sequence changes in HIV-1 that may impact susceptibility to ARVs, and the estimation of the proportion of HIV-positive women who have chronic versus recent HIV infection.

The finding of significant resistance, or lack thereof, to ARV-based study products delivered vaginally or taken orally may guide decisions related to future microbicide and PrEP studies. In addition, MTN-009 will provide valuable comparison data for the resistance data obtained in MTN-015, the MTN seroconverter study.

• Study Type: Observational
• Enrollment (Actual): 1074

Contacts and Locations

Study Locations

• South Africa
  • KwaZulu Natal
    • Durban, KwaZulu Natal, South Africa
      • South African Medical Research Council, Botha's Hill
    • Durban, KwaZulu Natal, South Africa
      • South African Medical Research Council, Isipingo
    • Durban, KwaZulu Natal, South Africa
      • South African Medical Research Council, RK Khan (Chatsworth)
    • Durban, KwaZulu Natal, South Africa
      • South African Medical Research Council, Umkomaas
    • Durban, KwaZulu Natal, South Africa
      • South African Medical Research Council, Verulam
    • Tongaat, KwaZulu Natal, South Africa
      • South African Medical Research Council
  • KwaZulu-Natal
    • Durban, KwaZulu-Natal, South Africa, 3630
      • South African Medical Research Council, HIV Prevention Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women of reproductive age who are interested in participating in HIV prevention trials

Description

Inclusion Criteria:

• Present to an MTN-009 study site to pre-screen or screen for an HIV prevention trial
• Age 18-40 years, verified per site standard operating procedures (SOP)
• Able and willing to provide written informed consent for participation in MTN-009
• Able and willing to provide adequate locator information, as defined in site SOPs

Exclusion Criteria:

• Any condition that, in the investigator's opinion, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achievement of the study objectives

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the frequency of HIV drug resistance mutations among women who test HIV-positive when presenting to screen for participation in HIV prevention trials	Mutations in HIV-1 reverse transcriptase and protease known to be associated with drug resistance	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To identify and evaluate behavioral indicators including self or sexual partner(s) exposures to ARV drugs as risk factors for drug resistant HIV infection in women who present for screening to participate in HIV prevention trials	Participant self-reported ARV drug exposures and other behaviors or herself or sexual partner(s) that may be associated with risk of drug resistant HIV-1 infections	2 years
• To characterize the degree of immunodeficiency and risk of disease progression by quantifying plasma HIV-1 RNA and CD4-positive T cells among women who test HIV-positive when presenting for screening to participate in HIV prevention trials	• Plasma HIV-1 RNA levels and CD4-positive T cell counts Plasma HIV-1 RNA levels and CD4-positive T cell counts	2 years

Collaborators and Investigators

• Sponsor: Microbicide Trials Network
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Study Chair: Urvi Parikh, PhD, MTN Virology CORE

Publications and helpful links

General Publications

• Parikh UM, Kiepiela P, Ganesh S, Gomez K, Horn S, Eskay K, Kelly C, Mensch B, Gorbach P, Soto-Torres L, Ramjee G, Mellors JW; MTN-009 Protocol Team. Prevalence of HIV-1 drug resistance among women screening for HIV prevention trials in KwaZulu-Natal, South Africa (MTN-009). PLoS One. 2013 Apr 9;8(4):e59787. doi: 10.1371/journal.pone.0059787. Print 2013. Erratum In: PLoS One. 2014;9(1). doi:10.1371/annotation/8096d24f-06de-4e42-8834-b5d3e116253c. IPTc Taskforce [corrected to MTN-009 Protocol Team].
• Mensch BS, Gorbach PM, Kelly C, Kiepiela P, Gomez K, Ramjee G, Ganesh S, Morar N, Soto-Torres L, Parikh UM. Characteristics Associated with HIV Drug Resistance Among Women Screening for an HIV Prevention Trial in KwaZulu-Natal, South Africa. AIDS Behav. 2015 Nov;19(11):2076-86. doi: 10.1007/s10461-015-1056-4.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: September 16, 2010
• First Submitted That Met QC Criteria: September 16, 2010
• First Posted (Estimate): September 17, 2010

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: HIV; Drug resistance; mutations; ARV's
• Other Study ID Numbers: MTN-009; 5U01AI068633-04 (U.S. NIH Grant/Contract)