https://doi.org/10.17037/DATA.00001927
The longitudinal follow-up of women in the HPTN 071 (PopART) trial in two schistosomiasis-endemic communities in Zambia provided an opportunity for a nested study of the association of Female Genital Schistosomiasis (FGS) with HIV-1 incidence. In the bilharzia and HIV (BILHIV) study, we conducted an array of diagnostic tests for S. haematobium infection and FGS, demonstrating that self-collected genital swabs had comparable sensitivity to clinic-based, midwife-collected CVL for the detection of Schistosoma DNA by real-time PCR. HIV-1 outcomes were available for the HPTN 071 (PopART) Population Cohort at final follow-up. BILHIV study participants were consecutively recruited from the Population Cohort, providing the opportunity to compare the rate of incident HIV-1 infection in women with and without FGS, with power ultimately determined by the number of HIV seroconversion events in this nested study.
Names and other direct identifiers have been removed prior to submission. Participant age and other information that may be used to identify participants in combination with other data has been placed into broad categories to reduce the disclosure risk. However, there remain a number of unique measurements. These values will be removed when preparing data for access.
Data may only be shared for use in health research, where ethical approval for the work has been obtained.
The cross-sectional bilharzia and HIV (BILHIV) study was nested in HPTN 071 (PopART), a cluster randomized trial to measure the impact of an HIV-1 combination prevention package. The same ethics approvals apply.
| Dataset variable name | Description | Variable Information | Response code | Response label |
| seroconfl | HIV-1 seroconversion status | Did the participant seroconvert to HIV-1 positive during the study? (women HIV positive at study entry are missing) | ||
| 0 | No HIV seroconversion during the study | |||
| 1 | HIV seroconverstion during the study | |||
| PCRVS | Laboratory result | Schistosoma PCR result - Vaginal swab | ||
| 0 | Negative | |||
| 1 | Positive | |||
| PCRCS | Laboratory result | Schistosoma PCR result - Cervical swab | ||
| 0 | Negative | |||
| 1 | Positive | |||
| PCRCVL | Laboratory result | Schistosoma PCR result - Cergicovaginal lavage | ||
| 0 | Negative | |||
| 1 | Positive | |||
| district | Study community | Is the patient being recruited in community A or Community B? | ||
| 1 | Community A | |||
| 2 | Community B | |||
| DEMEMP | Employment status | Are you currently working? | ||
| 0 | No | |||
| 1 | Yes | |||
| CONTRACON | Contraceptive use | Do you use condoms for contraception? | ||
| 0 | No | |||
| 1 | Yes | |||
| CONTRAOCP | Contraceptive use | Do you use oral contraceptive tablets for contraception? | ||
| 0 | No | |||
| 1 | Yes | |||
| CONTRAINJ | Contraceptive use | Do you use injectable hormonal contraception? | ||
| 0 | No | |||
| 1 | Yes | |||
| CONTRAIMP | Contraceptive use | Do you use implants for contraception? | ||
| 0 | No | |||
| 1 | Yes | |||
| micropos | Schistosoma infection status | Binary urine microscopy result | ||
| 0 | Negative | |||
| 1 | Positive | |||
| CAAbinary | Schistosoma infection status | Binary CAA result | ||
| 0 | Negative | |||
| 1 | Positive | |||
| NULL | 2 vials were empty on arrival to Leiden University Med Center | |||
| definite | Presence of any genital PCR positive | Study generated variable | ||
| probable | Presence of probable Female Genital Schistosomiasis (FGS) | Study generated variable | ||
| possible | Presence of possible Female Genital Schistosomiasis (FGS) | Study generated variable | ||
| definite1 | Presence of any genital PCR positive (women with probable FGS excluded) | Study generated variable | ||
| 0 | Negative | |||
| 1 | Positive | |||
| NULL | 25 women with probable FGS are made missing | |||
| probable1 | Presence of probable FGS (women with definite FGS excluded) | Study generated variable | ||
| 0 | Negative | |||
| 1 | Positive | |||
| NULL | 28 women with definite FGS are made missing | |||
| pcr23pos | Subgroup analysis of women with genital PCR positive (definite FGS), but with 2-3 positive PCR | Study generated variable | ||
| 0 | negative FGS | |||
| 1 | pcr for FGS positive and 2-3 specimens PCR positive | |||
| NULL | probable fgs and/or women with 1 positive PCR | |||
| crowding1 | Number of household members | Including yourself, how many total household members are there? | ||
| 0 | 1-3 people living in household | |||
| 1 | 4-5 people living in household | |||
| 2 | 6+ people living in household | |||
| edu3 | Education | What is your level of education? | ||
| 0 | No schooling/Any primary school | |||
| 1 | Any secondary school | |||
| 2 | Trade/degree/or higher | |||
| marst1 | Marital status | What is your marital status? | ||
| 1 | Single | |||
| 2 | Married or living as married | |||
| 3 | Divorced/separated/widowed | |||
| sexin6 | Recent sexual activity | Have you been sexually active in the last 6 months? | ||
| 0 | No | |||
| 1 | Yes | |||
| NULL | 2 people preferred not to answer and were made missing | |||
| sti | Self-reported history of Sexually Transmitted Infections (STI) | Have you ever had an STI? | ||
| 0 | No | |||
| 1 | Yes | |||
| NULL | 1 person preferred not to answer and was made missing | |||
| condomuse | Self-reported condom use | During your last sexual encounter, did your partner wear a condom? | ||
| 0 | No | |||
| 1 | Yes | |||
| NULL | 10 people preferred not to answer and were made missing | |||
| sexdebut | Age at sexual debut | How old were you when you had sex for the first time? | ||
| 0 | age 8-16 | |||
| 1 | age 17-19 | |||
| 2 | age 20+ | |||
| NULL | 1 person preferred not to answer and was made missing | |||
| partners1 | Number of lifetime partners | Number of lifetime partners | ||
| 0 | 1 lifetime partner | |||
| 1 | 2 lifetime partner | |||
| 2 | 3 lifetime partners | |||
| 3 | 4+ lifetime partners | |||
| mhighct1 | Subgroup analysis of women with genital PCR positive (definite FGS), but with Schistosoma DNA PCR Ct <35 | Study generated variable | ||
| 0 | negative FGS | |||
| 1 | pcr for FGS positive and <35ct | |||
| NULL | probable fgs and/or women with positive PCR and ct>35 | |||
| fgs1 | FGS status | Are sandy patches (sandy or homogenous yellow) or abnormal vessels visualized on portable colposcopy? | ||
| 0 | No visual FGS | |||
| 1 | Visual FGS (sandy patch or abnormal vessel) | |||
| 999 | Not applicable (missing colposcopy image file or file not interpretable) | |||
| active1 | Schistosoma infection status | Is active schistosome infection present (positive CAA or urine microscopy)? | ||
| 0 | Negative | |||
| 1 | Positive | |||
| NULL | 2 vials were empty on arrival to Leiden University Med Center | |||
| hivtime | Calculated variable | Length of follow-up, calculated from study entry to censoring | ||
| equiv223pcr30 | FGS status - exploratory analysis variable | FGS status used in poisson regression - subgroup analysis of women with 2-3 positive Schistosoma PCRs | ||
| 0 | FGS negative | |||
| 1 | FGS with 2-3 pcr positive | |||
| NULL | all others are made missing (missing/probable/possible/FGS and 1 pcr positive) | |||
| equiv2ct35 | FGS status - exploratory analysis variable | FGS status used in poisson regression - subgroup analysis of women positive Schistosoma PCR and Ct<35 | ||
| 0 | FGS negative | |||
| 1 | FGS with Schistosoma DNA PCR Ct<35 | |||
| NULL | all others are made missing (missing/probable/possible/FGS and 1 pcr positive) | |||
| rhfgs | FGS status | FGS status used in poisson regression | ||
| 0 | FGS negative + FGS possible/probable | |||
| 1 | FGS | |||
| NULL | 96 women who had missing images were made missing for the comparison of FGS vs (FGS negative + FGS probable/possible) | |||
| rhpp | FGS status | Probable/possible FGS status used in poisson regression | ||
| 0 | FGS negative + FGS | |||
| 1 | FGS probable/possible | |||
| NULL | 96 women who had missing images (n=96) were made missing for the comparison of "probable/possible FGS" vs (FGS+ FGS negative) | |||
| agegp4 | Categorical variable for age | How old are you? | ||
| 1 | age 18-24 | |||
| 2 | age 25-31 |