Condom Promotion and Counseling Study
What was HIVNET 016a?
A study 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.
Who participated in the study?
3,000 women, regardless of HIV serostatus, attending postnatal and family planning clinics in Blantyre and Lilongwe, Malawi, and Harare, Zimbabwe.
What happened during the study?
Behavioral counseling messages for five visits over two months; subsequent quarterly visits with HIV pre-test, risk reduction, and post-test counseling.
Results
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.
Study Documents
Study Details
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.
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.
Women, regardless of HIV serostatus, attending postnatal and family planning clinics in Blantyre and Lilongwe, Malawi, and Harare, Zimbabwe.
3000 women total (1000 per site)
14 months for each participant.
Behavioral counseling messages for 5 visits over 2 months; subsequent quarterly visits with HIV pre-test, risk reduction, and post-test counseling.
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.
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).