Contraception, HIV, HIV Infections
Conditions
Keywords
HIV/AIDS, Contraception, Birth control, CD4+, Viral Load, T-cell activation, B-cell activation, Hormonal, Intrauterine device, Depo Provera, Women, IUCD, treatment naive
Brief summary
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
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.
Interventions
DRUGDepo Provera
Depo Provera administered by injection at randomization visit and the 12-week study visit.
DEVICECopper T Intrauterine contraception device
IUCD inserted upon randomization to this study arm
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| T-cell activation | 4, 8, 12, and 24 weeks post-randomization |
Secondary
| Measure | Time frame |
|---|---|
| CD4+ cell decline | 4, 8, 12, and 24 weeks post-randomization |
| Cervical viral load | 4, 8, 12, and 24 weeks post-randomization |
Countries
Zambia
Outcome results
None listed