Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,074

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2010

Shorter than P25 for all trials

Geographic Reach

1 country

7 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

11 months study duration

Study Start

First participant enrolled

August 1, 2010

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

7 months

First QC Date

September 16, 2010

Last Update Submit

June 17, 2021

Conditions

HIV

Keywords

HIVDrug resistancemutationsARV's

Outcome Measures

Primary Outcomes (1)

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 Outcomes (2)

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
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
2 years

Eligibility Criteria

Age18 Years - 40 Years

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64)

Sampling MethodNon-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Microbicide Trials Networklead
National Institute of Allergy and Infectious Diseases (NIAID)collaborator

Study Sites (7)

South African Medical Research Council, HIV Prevention Research Unit

Durban, KwaZulu-Natal, 3630, South Africa

Location

South African Medical Research Council, Botha's Hill