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Study
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Phase Definitions
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HIVNET 016A
Condom Promotion and
Counseling Study
What is
HIVNET 016A?
HIVNET
016A is a study intended to prepare women to participate in a Phase III
clinical trial of vaginal microbicides. During a preparatory period,
condom promotion and counseling were carried out and the effectiveness of
this educational activity on uptake and consistent use of male condoms
will be determined. The study sites involved in this protocol were
prepared to initiate a Phase III effectiveness trial of the vaginal
microbicide Conceptrol gel (100 mg nonoxynol-9 (N-9) gel per application),
the HIVNET 016 trial. However, the results of a Phase III trial of a 52 mg
N-9 gel (AdvantageS), conducted by UNAIDS and presented at the XIII
International AIDS Conference in Durban, South Africa, suggested that N-9
users had a higher rate of HIV incidence than placebo users. This
information combined with the results of other clinical trials of N-9,
which showed that N-9 was either not effective or marginally beneficial,
led the protocol team to reconsider this product.
The Phase III portion of
the HIVNET 016 trial was canceled prior to enrollment and randomization of
women into the appropriate study arms. Study participants participated in
an extensive Condom Promotion and Counseling study in order to maintain the research infrastructure that has been
established. Data was collected on condom use, incidence and
prevalence of STDs, and additional information that will improve the
quality of future Phase III vaginal microbicide trials.
A
total of 2016 HIV-negative women from Malawi and Zimbabwe were enrolled in
the condom promotion and counseling phase of the study. Of these,
1679 were tested for HIV during follow-up and 113 seroconverted, resulting
in overall HIV incidence rate of 4.7 per 100 women-years (95% CI 3.8-5.6).
Incidence rates were similar across sites. The major predictors of
HIV acquisition were young age, presence of STIs, being unmarried, and
higher educational level. Results of the study
have been published in the journal Sexually Transmitted Diseases.
The full citation for the article is:
HIV Incidence Among Women of Reproductive Age in Malawi and
Zimbabwe. N Kumwenda, I Hoffman, M Chirenje, C Kelly, A Coletti, A
Ristow, et al. Sexually Transmitted Diseases, July 2006, Vol
33, No. 11: 646-51.
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Protocol Status:
Concluded
Study Summary
Study Purpose: To evaluate the effectiveness of condom promotion and counseling messages on uptake of condoms as a means to prevent HIV transmission in women attending postnatal and family planning clinics in Malawi and Zimbabwe.
Study Design: Participants were counseled in HIV prevention, condom use and negotiation skills during 5 visits over 2 months. HIV-negative participants who completed this program also complete quarterly follow-up visits to collect information on continued condom use and sexual behavior in order to generate knowledge and prepare for a Phase III microbicide effectiveness trial.
Study Population: Women, regardless of HIV serostatus, attending postnatal and family planning clinics in Blantyre and Lilongwe, Malawi, and Harare, Zimbabwe.
Study Size: 3000 women total (1000 per site)
Study Sites: Blantyre, Malawi; Lilongwe, Malawi; Harare, Zimbabwe
Study Duration: 14 months for each participant.
Treatment Regimen: Behavioral counseling messages for 5 visits over 2 months; subsequent quarterly visits with HIV pre-test, risk reduction, and post-test counseling.
Primary Objectives: To evaluate the effectiveness of condom promotion and counseling messages on uptake of condoms as a means to prevent HIV transmission by comparing the prevalence of consistent condom use (defined as using condoms in more than 75% of coital acts) at enrollment versus the end of an 8-week intensive condom promotion counseling program.
To evaluate the overall effectiveness of condom promotion and counseling messages on continued use of condoms as a means to prevent HIV transmission by comparing the prevalence of consistent condom use at the condom promotion exit visit with the prevalence of consistent condom use during quarterly visits following the condom promotion counseling program.
Secondary Objectives: To determine the incidence of HIV-1
To determine the incidence of other STDs (GC, CT, TV, HIV, syphilis), yeast, bacterial vaginosis and genital lesions (in HIV-1 uninfected women)
To determine the prevalence of HIV-1
To determine the prevalence of other STDs (GC, CT, TV, HIV, syphilis), yeast, bacterial vaginosis and genital lesions (in HIV-1 uninfected and infected women)
To determine feasibility of recruiting a large study cohort (1000 participants per site) with high retention rates (>90% over one year).
Protocol Co-Chair:
Nancy Padian
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Protocol Chair:
Taha Taha
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CORE Protocol Specialist:
Anne Coletti
get info
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