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

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.

Study Overview

• Status: Completed
• Conditions: Acquired Immunodeficiency Syndrome; HIV
• Intervention / Treatment: Behavioral: Enhanced Counseling; Behavioral: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 1500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Durban, South Africa
    • University of KwaZulu-Natal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Counseling; 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.	Behavioral: Enhanced Counseling; Women in the enhanced counseling arm receive the following intervention package: a video prior to their HIV pre-test counseling session that prepares them for decisions they will have to make regarding HIV testing and PMTCT participation, a pre-test counseling session and post-test counseling session with their nurse midwife/counselor, and two additional post-test counseling sessions with the same nurse midwife at 6 and 10 weeks postpartum. Women in the enhanced counseling arm also have access to ongoing support groups and legal support if needed at the clinic.
Active Comparator: Standard of Care; 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.	Behavioral: Standard of Care; Women in the standard of care arm receive HIV pre and post-test counseling at their first antenatal visit. The counseling provided to them adheres to international guidelines for HIV counseling and testing developed by US CDC and the World Health Organization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of KwaZulu
• Investigators: Principal Investigator: Suzanne Maman, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Dhayendre Moodley, MMedSc, PhD, University of KwaZulu

Publications and helpful links

General Publications

• Maman S, Moodley D, McNaughton-Reyes HL, Groves AK, Kagee A, Moodley P. Efficacy of enhanced HIV counseling for risk reduction during pregnancy and in the postpartum period: a randomized controlled trial. PLoS One. 2014 May 13;9(5):e97092. doi: 10.1371/journal.pone.0097092. eCollection 2014.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: September 7, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimate): September 11, 2012

Study Record Updates

• Last Update Posted (Estimate): September 12, 2012
• Last Update Submitted That Met QC Criteria: September 10, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: HIV; AIDS
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immune System Diseases; Slow Virus Diseases; HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
• Other Study ID Numbers: 07-1070; R01HD050134 (U.S. NIH Grant/Contract)