Clinical trial NCT01683461: Efficacy of HIV Post-Test Support for ANC in South Africa
Official title: Efficacy of HIV Posttest Support for ANC in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Acquired Immunodeficiency Syndrome
Keywords: HIV
AIDS
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of KwaZulu
First posted: 2012-09-11
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Incidence of sexually transmitted disease
timeFrame: 14 weeks post-partum
Secondary outcomes:
measure: Condom use
timeFrame: 14 weeks and 9 months post-partum
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: University of KwaZulu-Natal
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Suzanne Maman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of KwaZulu
name: Dhayendre Moodley, MMedSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.