HIV Clinical Trial
— SAHAPSOfficial 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.
Status | Completed |
Enrollment | 1500 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Eligible women: 1. are at least 18 years old, 2. are not pregnant, 3. have never tested for HIV or had most recently tested negative for HIV at least 3 months prior to recruitment, 4. report having a primary partner who they have been with for at least 6 months, 5. plan to live in Durban for at least the next year, 6. plan to take their infant to the clinic for immunization visits, 7. are able to communicate in English or Zulu, and 8. do not need critical care for a high risk pregnancy that clinic staff is unable to provide. Exclusion Criteria: Women are ineligible if they: 1. are younger than 18 years; 2. are not pregnant; 3. have previously tested positive for HIV; 4. do not have a primary partner defined as someone they have been with for at least 6 months; 5. are not planning to reside in Durban for the next one year; 6. are unable to communicate in English or Zulu; 7. require care for high risk pregnancy that can not be provided by the clinic staff. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | University of KwaZulu-Natal | Durban |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of KwaZulu |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of sexually transmitted disease | The investigators are using biologic markers of three STIs (Trichomonas vaginalis, Neisseria gonorrhea and Chlamydia). All women are tested for STIs at baseline and 14-weeks post-partum. | 14 weeks post-partum | No |
Secondary | Condom use | The investigators are measuring consistent condom use, unprotected sex in the past 30 days, unprotected sex since delivery (at 9 months post-partum) | 14 weeks and 9 months post-partum | No |
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