Efficacy of HIV Post-Test Support for ANC in South Africa (SAHAPS)

University of North Carolina (UNC)

Status: Completed

Conditions: HIV; Acquired Immunodeficiency Syndrome

Treatments: Behavioral: Enhanced Counseling; Behavioral: Standard of Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01683461

07-1070

R01HD050134 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 1,500 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Enhanced Counseling

Experimental group

Description:

Women in the intervention arm receive: (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 focused 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.

Treatment:

Behavioral: Enhanced Counseling

Standard of Care

Active Comparator group

Description:

Women in the control arm receive the standard of care in terms of HIV counseling and testing during pregnancy. The standard of care for HIV counseling adheres to guidelines provided by the US Centers for Disease Control and the World Health Organization. Women receive one individual pre-test counseling session immediately before they are tested for HIV, and one individual post-test counseling session the same day that they are tested.

Treatment:

Behavioral: Standard of Care