HIV Clinical Trial
Official title:
Efficacy of HIV Posttest Support for ANC in South Africa
This is a randomized controlled intervention trial with 1,500 pregnant and postpartum women
to examine the efficacy of an enhanced model of ongoing post-test support for women
attending antenatal and postnatal care in KwaZulu-Natal, South Africa. Through the
intervention, the investigators will tailor voluntary counseling and testing (VCT) for HIV
to the ANC setting and provide a continuum of psychosocial support for pregnant women
through: (1) a standardized health education video before HIV pre-test counseling; (2) HIV
pre- and post-test counseling sessions that prepare women for decisions related to testing,
serostatus disclosure and anti-retroviral (ARV) prophylaxis and help women plan strategies
for sexual risk behavior change; (3) two additional post-test counseling sessions postpartum
focusing on legal education and referral, partner testing, sexual risk behavior change and
family planning decisions and; (4) an active referral system to post-test support groups run
by a clinically trained staff psychologist and (5) an active referral system to legal
services run by a lawyer at the clinic.
Through this intervention trial the investigators will be testing the following hypotheses:
H1: Women receiving the intervention will have significantly lower sexual risk of HIV at 14
weeks and 9-months post-partum as compared to women in the control arm. Sexual risk of HIV
will be measured by: STI incidence (Trichomonas vaginalis, Neisseria gonorrhea and
Chlamydia), consistent condom use, unprotected sex in past 30 days, and unprotected sex
since delivery.
H2: Women receiving the intervention will report significantly better outcomes related to
prevention of mother to child transmission (PMTCT) service uptake at 14 weeks and 9 months
post-partum as compared to women in the control arm. PMTCT service uptake will be measured
by acceptance of HIV VCT among HIV-positive and HIV-negative women; acceptance of ARVs,
adherence to national infant feeding guidelines, and family planning use among HIV-positive
women.
H3: Women in the intervention arm will report significantly better psychosocial outcomes at
14 weeks and 9 months post-partum as compared to women in the control arm. Psychosocial
outcomes will be measured by: perceived social support, emotional distress, and partner
violence among HIV-positive and HIV-negative women.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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