Contributions to the literature
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This hybrid cluster randomized controlled trial is the first to examine a multi-level safer conception counseling intervention for HIV serodiscordant couples implemented in the standard manner used in resource constrained settings vs. a higher intensity training and supervision approach.
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Findings demonstrated that the implementation approach with more provider training and more frequent supervision resulted in greater use of safer conception methods and was more cost-effective than the standard implementation approach.
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Regardless of implementation approach, the Our Choice intervention was more efficacious than usual care, demonstrating a large magnitude of effect.
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This is the first cost-effectiveness analysis of a multi-level safer conception counseling intervention and the first to include implementation strategy costs.
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Findings that adequate training and ongoing supervision are essential in promoting adoption of this complex health behavior and ultimately more cost-effective addresses gaps in the literature and may be applicable to the management of many other chronic illnesses.
Background
Methods
Study design
Randomization and masking
Patient and public involvement
Study setting and participants
Intervention conditions
Our Choice
Low vs. high intensity approaches to implementation
Usual care control
Measures
Primary outcomes | |
Use of appropriate reproductive method to achieve stated reproductive goal (among whole sample) | Client’s self-reported use of accurate SCM (if trying to conceive) or modern contraceptives (if not trying to conceive), as defined below. |
Accurate use of safer conception methods (among those trying to conceive) | Interviewer-rated criterion-based assessment of client’s self-reported use of timed condomless intercourse (TCI), manual self-insemination (MSI), or sperm washing. |
Use of modern contraceptives (among those not trying to conceive) | Client’s self-reported use of modern contraceptives (birth control pills, medroxyprogesterone acetate injection, intrauterine device, implant, or tubal ligation/vasectomy). |
Secondary outcomes | |
Any use of SCM (among those trying to conceive) | Client’s self-reported use of the following: TCI: Did you have condomless or “live” sex only on the 3 days each month in which you/your partner were/was most fertile? Sperm washing: Did you/your partner pay for technology that cleanses your/your partner’s sperm or semen of the HIV virus? MSI (among female clients): Did you/your partner ejaculate into a condom or container and then manually inject the semen into your/partner’s vagina? |
Use of any method to prevent pregnancy (among those not trying to conceive) | Use of modern contraceptives, consistent condom use, or abstinence. |
Pregnancy status | Whether or not female partner become pregnant during the study, confirmed via pregnancy test conducted by FP nurse. |
Partner seroconversion | Partner HIV status based on rapid HIV test conducted by clinic staff at month 12 or at post-pregnancy assessment. |
Covariates | |
Demographics | Age, sex, and education level (whether or not any secondary education was completed) as self-reported by client. |
HIV medical and care characteristics | HIV diagnosis date, ART status, most recent CD4 count and HIV viral load were abstracted from the clients’ clinic chart. |
Relationship/partner characteristics | Marital status, length of relationship, co-habitation with partner, partner’s age, and whether partner was using HIV pre-exposure prophylaxis (PrEP), all assessed via client self-report. |
Reproductive health history and behaviors | History of respondent or partner having biological children, having a child together, having been tested for infertility, or a health care provider ever telling them they may have fertility problems, and whether either had been diagnosed or (and treated for) a sexually transmitted infection in the prior 6 months, via client self-report. |
Primary outcome
Data analysis
Cost-effectiveness analysis
Results
Sample characteristics
Total sample (n=389) | Study completers (n=373) | Lost to follow-up (n=16) | P value | SCC1 (n=129) | SCC2 (n=130) | Usual care (n=130) | P value | |
---|---|---|---|---|---|---|---|---|
Mean (SD)/n (%) | Mean (SD)/n (%) | Mean (SD)/n (%) | Mean (SD)/n (%) | Mean (SD)/n (%) | Mean (SD)/n (%) | |||
Sociodemographic characteristics | ||||||||
Age (years) | 35.9 (8.2) | 35.9 (8.1) | 34.1 (10.5) | 0.372 | 35.1 (7.2) | 35.3 (8.0) | 37.1 (9.1) | 0.095 |
Female sex | 195 (50.3%) | 187 (50.1%) | 8 (50.0%) | 0.992 | 78 (60.5%) | 66 (50.8%) | 51 (39.2%) | 0.003 |
Some secondary education | 132 (33.9%) | 126 (33.8%) | 6 (37.5%) | 0.758 | 34 (26.4%) | 49 (37.7%) | 49 (37.7%) | 0.084 |
HIV disease characteristics | ||||||||
Time since HIV diagnosis (years) | 10.7 (8.7) | 10.6 (8.7) | 13.2 (9.7) | 0.241 | 11.0 (9.1) | 9.6 (8.6) | 11.5 (8.5) | 0.191 |
CD4 count (cells/mm3)a | 518 (293) | 524 (294) | 391 (247) | 0.142 | 537 (287) | 535 (319) | 483 (273) | 0.400 |
Undetectable HIV viral load (n=315)b | 265 (83.9%) | 255 (84.2%) | 10 (76.9%) | 0.487 | 90 (87.4%) | 78 (78.8%) | 97 (85.1%) | 0.229 |
Currently on ART | 385 (99.2%) | 369 (99.2%) | 16 (100%) | 0.718 | 129 (100%) | 128 (98.5%) | 128 (99.2%) | 0.368 |
Time on ART (years)c | 7.8 (7.1) | 7.8 (7.1) | 8·5 (7.2) | 0.710 | 7.7 (7.5) | 7.4 (7.0) | 8.5 (6.7) | 0.431 |
Partner and relationship characteristics | ||||||||
Married to partner | 326 (83.8%) | 312 (83.7%) | 14 (87.5%) | 0.682 | 113 (87.6%) | 102 (78.5%) | 111 (85.4%) | 0.114 |
Length of relationship (years) | 9.9 (10.7) | 10.0 (10.8) | 9.6 (9.5) | 0.907 | 9.3 (9.6) | 9.4 (11.1) | 11.0 (11.3) | 0.363 |
Currently living with partner | 344 (88.4%) | 329 (88.2%) | 15 (93.8%) | 0.497 | 116 (89.9%) | 114 (87.7%) | 114 (87.7%) | 0.811 |
Reproductive history and behavior | ||||||||
Using modern contraceptives | 71 (18.3%) | 69 (18.5%) | 2 (12.5%) | 0.543 | 23 (17.8%) | 27 (20.8%) | 21 (16.2%) | 0.622 |
Participant has biological children | 349 (89.7%) | 335 (89.8%) | 14 (87.5%) | 0.766 | 118 (91.5%) | 112 (86.2%) | 119 (91.5%) | 0.261 |
Has had a child with partner | 195 (50.1%) | 187 (50.1%) | 8 (50.0%) | 0.992 | 59 (45.7%) | 63 (48.5%) | 73 (56.2%) | 0.220 |
Fidelity to Our Choice intervention
Intervention effects on primary and secondary outcomes
Overall | SCC1 | SCC2 | Sig. test(unadjusted) | Intervention effect(covariate adjusted) | Intervention(SCC1/SCC2) | Usual care control | Sig. test(unadjusted) | Intervention effect(covariate adjusted) |
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n (%) | n (%) | Chi-sq | OR (95% CI) | n (%) | n (%) | Chi-sq | OR (95% CI) | |
Among all participants in the sample (n=389) | ||||||||
n | 129 | 130 | 259 | 130 | ||||
Primary outcome: Used SCM accurately if tryingto conceive or modern contraception if not tryingto conceive | 35 (27.1%) | 19 (14.6%) | 0.013 | 4.50** (1.44-14.01) | 54 (20.8%) | 9 (6.9%) | <0.001 | 10.63** (2.79-40.49) |
Secondary outcomes: Used SCM accurately iftrying to conceive or any contraception(incl condoms) if not trying to conceive | 46 (35.7%) | 33 (25.4%) | 0.073 | 3.44* (1.31-9.02) | 79 (30.5%) | 27 (20.8%) | 0.042 | 3.63** (1.38-9.61) |
Partner seroconversion to HIV positive at studyendpoint | 0 (0%) | 1 (0.8%) | 0.320 | 0.94 (0.01-75.66) | 1 (0.4%) | 0 (0%) | 0.46 | 2.23 (0.02-257.6) |
Among those trying to conceive throughout study (n=212) or during one 6-month period (n=64): total n=276 | ||||||||
n | 104 | 87 | 191 | 85 | ||||
Primary outcome: Used TCI or MSI accurately | 36 (34.6%) | 10 (11.5%) | <0.001 | 6.43** (1.90-21.73) | 46 (24.1%) | 0 (0%) | <0.001 | 91.84** (4.94-1709) |
Secondary outcomes | ||||||||
Used any (un-named) strategy to reduce risk inconceiving | 81 (77.9%) | 61 (70.1%) | 0.221 | 7.05** (2.07-23.99) | 142 (74.3%) | 26 (30.6%) | <0.001 | 27.17** (7.84-94.15) |
Reported using SCM (TCI/MSI) | 75 (72.1%) | 50 (57.5%) | 0.034 | 4.75** (1.64-13.71) | 125 (65.4%) | 4 (4.7%) | <0.001 | 494.4** (26.06-9378) |
Reported using TCI | 67 (64.4%) | 42 (48.3%) | 0.025 | 5.12** (1.86-14.50) | 109 (57.1%) | 4 (4.7%) | <0.001 | 424.6** (22.63-7968) |
Reported accurate TCI | 30 (28.8%) | 9 (10.3%) | 0.002 | 10.33** (2.60-41.08) | 39 (20.4%) | 0 (0%) | <0.001 | 121.9** (6.30-2360) |
Reported using MSI (among females) | 14/69 (20.3%) | 8/39 (20.5%) | 0.978 | 1.06 (0.27-4.11) | 22/108 (20.4%) | 0/34 (0%) | 0.002 | 9.88 (0.48-201.9) |
Reported accurate MSI | 8/69 (11.6%) | 1/39 (2.6%) | 0.152 | 1.13 (0.13-9.54) | 9/108 (8.3%) | 0/34 (0%) | 0.114 | 2.77 (0.11-67.26) |
Became pregnant | 32 (30.8%) | 29 (33.3%) | 0.760 | 0.44 (0.15-1.25) | 61 (31.9%) | 27 (31.8%) | 0.902 | 0.73 (0.25-2.09) |
Among those not trying to conceive throughout study (n=113) or in one 6-month time period (n=64): total n=177 | ||||||||
n | 48 | 61 | 109 | 68 | ||||
Primary outcome: Using modern contraceptive | 7 (14.6%) | 12 (19.4%) | 0.487 | 3.72 (0.37-37.48) | 19 (17.4%) | 12 (17.6%) | 0.971 | 1.20 (0.22-6.501) |
Secondary outcomes: | ||||||||
Using modern contraceptive or always usecondoms or not having sex | 28 (58.3%) | 35 (56.5%) | 0.92 | 1.07 (0.28-4.19) | 63 (57.8%) | 37 (54.4%) | 0.658 | 0.52 (0.16-1.75) |
Always use condoms | 13 (27.1%) | 16 (25.8%) | 0.92 | 2.78 (0.50-15.63) | 29 (26.6%) | 18 (26.5%) | 0.984 | 2.66 (0.57-12.44) |
Did not become pregnant | 44 (91.7%) | 54 (88.5%) | 0.589 | 1.40 (0.17-11.58) | 98 (89.9%) | 61 (89.7%) | 0.965 | 0.18 (0.01-4.30) |