Impact of Different Contraceptives on the Immune System of HIV Infected Women in Zambia

Study Overview
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Brief Summary
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In this study, 66 HIV-infected women who desire contraception will be randomly assigned to use either an IUD or Depo Provera, and will be followed for six months. The study is intended to help investigators understand potential mechanisms by which hormonal contraception may hasten HIV disease progression.

Detailed Description
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In this randomized controlled trial, 66 HIV-infected women who desire contraception will be assigned to one of two treatment groups: IUD or Depo Provera. The study builds on findings from a previous study which examined the safety and acceptability of hormonal contraception and IUD among HIV-infected women. Secondary analyses from the previous study indicated that women who were assigned to the hormonal arm appeared to have faster disease progression based on death and decline in CD4+ count as compared to women assigned to the IUD arm. With the current study, investigators seek to understand potential mechanisms for the effect of hormonal contraception on hastening HIV disease progression. Enrolled women will be asked to use the assigned contraception method for a period of six months, and various indicators of disease progression will be collected at four follow-up visits after randomization.

Official Title
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Mucosal and Systemic Responses to Contraceptives in HIV-Infected Women in Zambia

Conditions
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HIV, Contraception, HIV Infections

Intervention / Treatment
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* Drug: Depo Provera
* Device: Copper T Intrauterine contraception device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed HIV status by local rapid test algorithm Willingness to be randomized to a contraceptive method and continue that method for at least 6 months. Intention to stay in the study area for at least 6 months Exclusion Criteria: Currently pregnant or pregnant within the prior 6 months Currently breastfeeding Documented liver disease History of coagulation disorder Active tuberculosis Anemia, defined as Hgb <8gm/dL Age < 16 years (the age of consent in Zambia); Eligible for antiretroviral therapy based on Zambian National Guidelines (CD4+ < 200, or WHO stage IV, or CD4+< 350 and WHO stage III) Currently using an IUD or hormonal method of contraception, or have used a hormonal contraceptive in the past 6 months

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IUCD<br>Assigned to use a copper intrauterine device | Device: Copper T Intrauterine contraception device<br>* IUCD inserted upon randomization to this study arm<br>* Other names: ParaGuard TCu 380A;|
| Active Comparator: DMPA<br>Assigned to use Depo Provera | Drug: Depo Provera<br>* Depo Provera administered by injection at randomization visit and the 12-week study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T-cell activation |  | 4, 8, 12, and 24 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4+ cell decline |  | 4, 8, 12, and 24 weeks post-randomization | 
| Cervical viral load |  | 4, 8, 12, and 24 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV/AIDS, Contraception, Birth control, CD4+, Viral Load, T-cell activation, B-cell activation, Hormonal, Intrauterine device, Depo Provera, Women, IUCD, treatment naive