Table 3.

Key question 3: HIV disease transmission to noninfected male partners or markers of infectivity among women with HIV using IUDs

Author, year, location, support	Study design	Population	IUD type	HIV disease severity at baseline	Outcomes	Results	Strengths	Limitations	Quality grading
European Study Group [20], 1992 9 European countries Commission of the European Communities	Cohort	10 women with HIV using IUDs 86 women with HIV using no contraceptive	IUD (type not specified)	Most stage II or III with CD4 count >200×10⁶/L 36 women stage IV or CD4 count <200×10⁶/L	Seroconversion of male partner	Male partners of IUD users: 10% (n=1/10) seroconverted Male partners ofwomen using no method: 12% (n=10/86) seroconverted Not significant (exact p value not reported but not identified as significant)	Multiple countries	Small sample size for comparison of interest Index cases primarily drug users (may limit generalizability) Length of follow up not stated Response rates and follow-up rates not reported IUD type not specified Unclear if reported IUD use was at baseline or at time of transmission Analysis not adjusted	II-2, poor
Mostad [22], 1997 Kenya NIH, Clinical Nutrition Research Unit	Cross-sectional	6 women with HIV using IUDs 182 women with HIV using no contraceptive	IUD (type not specified)	Mean CD4 count 452; 17% < 200; no information for IUD users	Cervical HIV-1 DNA (swab) Vaginal HIV-1 DNA (swab)	Odds of cervical HIV-1 DNA among IUD users versus no method: OR 0.2 (95% CI=0.0–2.2) No vaginal HIV-1 DNA in IUD users		Small sample size of IUD users IUD type not specified Large percentage of sex workers (may limit generalizability) No information on ART use	II-3, Poor
Richardson [11], 1999 (follow up to Sinei [12], 1998) Kenya USAID	Prospective follow-up without comparison group	98 women with HIV initiating IUDs Follow up for 4 months	Copper IUD (copper T 380 A)	At 1 month follow-up, 7% had CD4 counts <200	Cervical HIV-1 DNA (endocervical swab)	No significant difference in prevalence of cervical shedding at 4 months (43%) compared with baseline (50%): adjusted OR 0.6 (95% CI=0.3–1.1)	Physicians performing exams were blinded to woman's HIV status Timing of IUD insertion known Cervical shedding analysis controlled for confounders 76% follow-up at 4 months Study powered to detect clinically relevant change in cervical HIV-1 DNA	Small sample size Short follow up for changes in disease status No comparison group No information on ART use during study	II-3, fair
Kovacs [21], 2001 United States NIH, Agency for Health Care Policy and Research, CDC	Cross-sectional	Women with HIV using IUDs (N not stated)	IUD (type not specified)	32% CD4 count >500 cells/mm³ 50% CD4 count 200–499 cells/mm³ 18% CD4 count <200 cells/mm³ All on stable ART for 1 month	Genital HIV shedding (endocervical swab and cervicovaginal lavage)	No association of IUD use with genital HIV shedding (data not shown)	Included women with severe disease	Sample size using IUDs not stated IUD types not stated OR for comparison of IUD versus non-IUD users not shown	II-3, poor
Heikinheimo [8], 2006 Finland Helsinki University	Prospective follow-up without comparison group	12 women with HIV initiating IUDs Follow up for 12 months	LNG-IUD	CD4 count ≥0.35×10⁹ cells/mL 10 women using ART 2 women not using ART	Genital HIV RNA (cervicovaginal lavage)	Women usingART (N=10): Nodifference in genitalHIV RNA (6 women undetectable) Women not using ART (N=2): genital HIV RNA present in half of samples, level decreased in 1 woman and increased in 1 woman after IUD initiation	100% follow up at 12 months Timing of IUD insertion known	Small sample size No comparison group No information on women with severe disease	II-3, poor
Coleman [15], 2013 Kenya Puget Sound Partners for Global Health, American College of Obstetricians and Gynecologists, University of Washington	Prospective follow-up without comparison group	30 women with HIV initiating LNG-IUDs Follow up for 6 months	LNG-IUD	CD4 count >250 cells/μL No ART within 90 days of study entry	Genital HIV-1 RNA (endocervical secretions and cervical vaginal lavage)	No statistically significant change in genital HIV-1 RNA (p=.55)	25/30 (83%)with evaluable specimens at 6 months Timing of IUD insertion known	Small sample size Short follow up for changes in disease status No information on women with severe disease No comparison group No information on ART use during study	II-3, poor