AEGiS-13IAC: Feasibility of vaginal microbicide trials in northern Thailand with women attending family planning clinics and women postpartum.

13th International AIDS Conference

Durban, South Africa - July 9-July 14, 2000

Feasibility of vaginal microbicide trials in northern Thailand with women attending family planning clinics and women postpartum.

Int Conf AIDS 2000 Jul 9-14; 13:(abstract no. ThOrC661)

Kilmarx PH, Supawitkul S, Yanpaisarn S, Limpakarnjanarat K, Manopaiboon C, Korattana S, St Louis ME, Mastro TD
P. H. Kilmarx, HIV/AIDS Colloboration, DMS6 Bldg Moph Tivanon Road, Nonthaburi 11000, Thailand, Tel.: +665 374 4486, Fax: +665 371 1827, E-mail: pbk4@cdc.gov

BACKGROUND: To perform vaginal microbicide clinical trials, potential study population rates of enrollment, condom use, follow-up, and HIV incidence must be well characterized.

METHODS: We enrolled women from 11 family planning clinics and one postpartum ward in upper northern Thailand into a prospective, observational study. At enrollment and at 6- and 12-month follow-up visits, consenting women were interviewed and tested for HIV antibodies. To reduce HIV transmission risk, at each visit HIV testing for the husband and condom use were recommended, condom use was demonstrated, and male condoms were provided.

RESULTS: From family planning clinics, 655 women (54% of those recruited) were enrolled; 5.8% reported consistent condom use after 6 months; 96% returned for 12-month follow-up; and 1 women seroconverted (0.19 per 100 person-years). From the postpartum ward, 124 women (11% of those recruited) were enrolled; 9.1% reported consistent condom use after 6 months; 78% returned for 12-month follow-up; and none of the women seroconverted.

CONCLUSIONS: For the women recruited from family planning clinics, enrollment rates were adequate, follow-up rates were high, and condom use was low despite condom counseling, demonstration, and provision, all of which suggest that this would be a good population for microbicide safety and acceptability trials. Rates of enrollment and follow-up were lower for the postpartum women, suggesting that this is a less appropriate population for such studies. HIV incidence was low in both groups; thus, HIV-prevention efficacy trials do not seem feasible in this population.

Keywords: AEGIS, Family Planning Services, Condoms, Counseling, HIV Infections, Puerperium, Thailand, Safe Sex, HIV Antibodies, Condoms, Female, Incidence, Anti-Infective Agents, HIV Seropositivity, Human, Female, Male, immunology
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ThOrC661